<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04422327</url>
  </required_header>
  <id_info>
    <org_study_id>AFCRO-079</org_study_id>
    <nct_id>NCT04422327</nct_id>
  </id_info>
  <brief_title>The Impact of a Combination of Bifidobacterium Longum 35624® and 1714™ Strains in Adults With Irritable Bowel Syndrome</brief_title>
  <acronym>IBS</acronym>
  <official_title>An Open Label Study to Assess the Impact of 'COMBO' on Mood, Stress and Bowel Symptoms in Adults With Irritable Bowel Syndrome (IBS)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>PrecisionBiotics Group Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Atlantia Food Clinical Trials Ltd.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>PrecisionBiotics Group Ltd.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aimed to assess the impact of consumption of COMBO, a combination product of two&#xD;
      Bifidobacterium longum strains, on stress, mood and bowel symptoms in adults with Irritable&#xD;
      Bowel Syndrome (IBS).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an open label study designed to assess the impact on stress, mood and bowel symptoms&#xD;
      &amp; safety of COMBO, a combination of Bifidobacterium longum 35624® and Bifidobacterium longum&#xD;
      1714™ strains, when consumed once daily for 8 weeks, in adults with Irritable Bowel Syndrome&#xD;
      (IBS). Volunteers will be screened according to the selection criteria in order to identify&#xD;
      up to 40 female subjects, with recurrent abdominal pain/discomfort and mild to moderate&#xD;
      stress/mood status. The study will involve 6 visits over an 18 to 20-week period [Screening&#xD;
      period (Visit 1: week-2), Intervention period (Visit 2: week 0, Visit 3: week 4, Visit 4:&#xD;
      week 8), and Follow-up/ Washout period (Visit 5: week 12, Visit 6: week 16)]. Participants&#xD;
      will fill in daily and weekly eDiary from 1st visit onwards. Questionnaires will be&#xD;
      administered from visit 2 to visit 6. Research blood and saliva will also be collected at&#xD;
      these time points. Stool sample will be collected at Visit 2, 4, 5, 6.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 20, 2017</start_date>
  <completion_date type="Actual">February 12, 2018</completion_date>
  <primary_completion_date type="Actual">February 12, 2018</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Open label study, with intervention period followed by follow-up (wash out) period.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in stress and mood, assessed by Hospital Anxiety and Depression Scale (HADS) scores</measure>
    <time_frame>Assessed at baseline, 4 and 8 weeks of supplement intake, and 4 and 8 weeks post supplement intake.</time_frame>
    <description>HADS gives HADS-A and HADS-D scores; minimum score for each is 0, maximum score is 21. Higher scores indicate worse stress/mood.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Subject Global Assessment (SGA) of IBS symptoms, assessed by weekly eDiary</measure>
    <time_frame>Assessed weekly from baseline to 8 weeks post supplement intake.</time_frame>
    <description>Participants answer the question: &quot;Did you have adequate relief of your IBS symptoms over the past week?&quot; Yes or No.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Subject Global Assessment (SGA) of abdominal pain/discomfort, assessed by weekly eDiary</measure>
    <time_frame>Assessed weekly from baseline to 8 weeks post supplement intake.</time_frame>
    <description>Participants answer the question: &quot;Did you have adequate relief of your abdominal pain and discomfort over the past week?&quot; Yes or No.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in IBS-Symptom Severity Score (IBS-SSS)</measure>
    <time_frame>Assessed at baseline, 4 and 8 weeks of supplement intake, and 4 and 8 weeks post supplement intake.</time_frame>
    <description>IBS-SSS is a composite score of abdominal pain, number of days with abdominal pain, bloating/distension, satisfaction with bowel habits, and IBS-related quality of life (QoL). Scores range from 0 to 500, with higher scores indicating worse symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in stool frequency, assessed by daily eDiary</measure>
    <time_frame>Assessed daily from baseline to 8 weeks post supplement intake.</time_frame>
    <description>Daily diary of number of bowel movements.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in stool consistency (Bristol Stool Scale), assessed by daily eDiary</measure>
    <time_frame>Assessed daily from baseline to 8 weeks post supplement intake.</time_frame>
    <description>Daily diary of stool consistency of each bowel movement based on Bristol Stool Scale (Type 1-7).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in abdominal pain/discomfort, assessed by daily eDiary</measure>
    <time_frame>Assessed daily from baseline to 8 weeks post supplement intake.</time_frame>
    <description>Daily diary of Visual Analog Scale (VAS) of abdominal pain/discomfort.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in abdominal bloating/distension, assessed by daily eDiary</measure>
    <time_frame>Assessed daily from baseline to 8 weeks post supplement intake.</time_frame>
    <description>Daily diary of Visual Analog Scale (VAS) of abdominal bloating/distension.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in bowel movement urgency, assessed by daily eDiary</measure>
    <time_frame>Assessed daily from baseline to 8 weeks post supplement intake.</time_frame>
    <description>Daily diary of Visual Analog Scale (VAS) of bowel movement urgency.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in straining, assessed by daily eDiary</measure>
    <time_frame>Assessed daily from baseline to 8 weeks post supplement intake.</time_frame>
    <description>Daily diary of Visual Analog Scale (VAS) of straining.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in passage of gas, assessed by daily eDiary</measure>
    <time_frame>Assessed daily from baseline to 8 weeks post supplement intake.</time_frame>
    <description>Daily diary of Visual Analog Scale (VAS) of passage of gas.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Visceral Sensitivity Index</measure>
    <time_frame>Assessed at baseline, 4 and 8 weeks of supplement intake, and 4 and 8 weeks post supplement intake.</time_frame>
    <description>Visceral Sensitivity Index (VSI) is a self-report measure of the gastrointestinal symptom-specific anxiety (GSA) of patients with IBS, in terms of cognitive, emotional and behavioral responses. Sum scores range from 0 to 75 with higher scores indicating more severe GI-specific anxiety.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in sleep quality, assessed by Pittsburgh Sleep Quality Index (PSQI)</measure>
    <time_frame>Assessed at baseline, 4 and 8 weeks of supplement intake, and 4 and 8 weeks post supplement intake.</time_frame>
    <description>PSQI global score: minimum score is 0, maximum score is 21. Higher scores indicate worse sleep quality.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in cognition, assessed by Visual Analogue Scales</measure>
    <time_frame>Assessed at baseline, 4 and 8 weeks of supplement intake, and 4 and 8 weeks post supplement intake.</time_frame>
    <description>This assessment measures individual question answers related to hedonic tone, anxiety and alertness.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in cognition, assessed by spatial span test</measure>
    <time_frame>Assessed at baseline, 4 and 8 weeks of supplement intake, and 4 and 8 weeks post supplement intake.</time_frame>
    <description>This test measures span length, errors, number of attempts and latency.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in cognition, assessed by Stockings of Cambridge test</measure>
    <time_frame>Assessed at baseline, 4 and 8 weeks of supplement intake, and 4 and 8 weeks post supplement intake.</time_frame>
    <description>This test measures problems solved in minimum moves, mean moves per n-move problem, initial thinking time per n-move problems and subsequent thinking time per n-move problems.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in cognition, assessed by Paired Associates Learning test</measure>
    <time_frame>Assessed at baseline, 4 and 8 weeks of supplement intake, and 4 and 8 weeks post supplement intake.</time_frame>
    <description>This test measures errors, trials, memory scores and stages completed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety of the investigational product, assessed by number of participants with treatment-related adverse events</measure>
    <time_frame>Assessed through study completion, an average of 6 months.</time_frame>
    <description>Safety will be evaluated throughout the study on the basis of incidence of treatment-related serious and non-serious adverse events.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>IBS - Irritable Bowel Syndrome</condition>
  <condition>Depression, Anxiety</condition>
  <arm_group>
    <arm_group_label>Probiotic capsule</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The participants consume one probiotic capsule a day for 8 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Probiotic capsule</intervention_name>
    <description>Each probiotic capsule contains 5 x 10^8 CFU B. longum 35624® and 5 x 10^8 CFU B. longum 1714™ with corn starch and magnesium stearate.&#xD;
The probiotic capsule will be supplied by PrecisionBiotics Ltd.</description>
    <arm_group_label>Probiotic capsule</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        To be considered eligible for enrolment into the study, subjects must;&#xD;
&#xD;
          1. Be able to give written informed consent,&#xD;
&#xD;
          2. Be a Caucasian female, between 18 and 55 years of age,&#xD;
&#xD;
          3. Subject has Irritable Bowel Syndrome according to the Rome III Diagnostic Criteria:&#xD;
&#xD;
             Recurrent abdominal pain or discomfort** at least 3 days/month in the last 3 months&#xD;
             associated with two or more of the following:&#xD;
&#xD;
             i. Improvement with defecation&#xD;
&#xD;
             ii. Onset associated with a change in frequency of stool&#xD;
&#xD;
             iii. Onset associated with a change in form (appearance) of stool&#xD;
&#xD;
             Criterion fulfilled for the last 3 months with symptom onset at least 6 months prior&#xD;
             to diagnosis&#xD;
&#xD;
             ** &quot;Discomfort&quot; means an uncomfortable sensation not described as pain.&#xD;
&#xD;
          4. Subjects agree to complete symptom diaries and return completed diaries at all&#xD;
             sessions,&#xD;
&#xD;
          5. Subjects with mild to moderate score (8-14) on the HADS-A and/or HADS-D questionnaire,&#xD;
             Subjects will be excluded if there is greater than 1 point difference from the&#xD;
             screening to baseline scores,&#xD;
&#xD;
          6. Be willing to refrain from taking any dietary supplements or other fermented foods&#xD;
             that contain live bacteria during the study,&#xD;
&#xD;
          7. Be willing to refrain from taking any medications or preparations used in the therapy&#xD;
             of IBS (herbal, dietary supplements, homeopathic preparations, etc.) during the study&#xD;
             and from 4-weeks before the baseline visit,&#xD;
&#xD;
          8. Be willing to refrain from probiotic use 4 weeks before the baseline visit,&#xD;
&#xD;
          9. If using fiber supplements (e.g., Trifyba, Fybogel, Konsyl, Isogel, Regulan, Ispagel,&#xD;
             Celevac, Normacol), the dose and regimen have remained stable for at least 30 days and&#xD;
             the subject will continue the same dose and regimen throughout the length of the&#xD;
             trial,&#xD;
&#xD;
         10. If using products that contain nicotine or caffeine, agrees to continue current usage&#xD;
             levels throughout the length of the trial.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Subjects will be excluded from the study if they meet any of the below criteria;&#xD;
&#xD;
          1. Are less than 18 and greater than 55 years of age at the time of consent,&#xD;
&#xD;
          2. Females are pregnant, lactating or wish to become pregnant during the study. Female&#xD;
             subject is currently either of:&#xD;
&#xD;
               -  non-childbearing potential (i.e., physiologically incapable of becoming pregnant,&#xD;
                  including any female who is post-menopausal or any female who is surgically&#xD;
                  sterilized (via documented hysterectomy or bilateral tubal ligation). (For&#xD;
                  purposes of this study, postmenopausal is defined as one year without menses), OR&#xD;
&#xD;
               -  child bearing potential, the subject is eligible to enter and participate in this&#xD;
                  study if she is not lactating and has a negative urine pregnancy test at the&#xD;
                  screening visit, visit 2 and upon completion of the study at visit 7. The subject&#xD;
                  must also agree to one of the following methods of contraception:&#xD;
&#xD;
                  i. Complete abstinence from intercourse two weeks prior to administration of&#xD;
                  study drug, throughout the clinical trial, until the completion of follow-up&#xD;
                  procedures or for two weeks following discontinuation of the study medication in&#xD;
                  cases where subject discontinues the study prematurely. (Subjects utilizing this&#xD;
                  method must agree to use an alternate method of contraception if they should&#xD;
                  become sexually active and will be queried on whether they have been abstinent in&#xD;
                  the preceding 2 weeks when they present to the clinic for the Final Visit.) or,&#xD;
&#xD;
             ii. has a male sexual partner who is surgically sterilized prior to the Screen Visit&#xD;
             and is the only male sexual partner for that subject or,&#xD;
&#xD;
             iii. sexual partner(s) is/are exclusively female or,&#xD;
&#xD;
             iv. Oral contraceptives (either combined or progestogen only) with double-barrier&#xD;
             method of contraception consisting of spermicide with either condom or diaphragm.&#xD;
             (Women of child-bearing potential using an oral contraceptive in combination with a&#xD;
             double-barrier method of contraception are required to continue to use this form of&#xD;
             contraception for 1 week following discontinuation of study medication).&#xD;
&#xD;
             v. Use of double-barrier contraception, specifically, a spermicide plus a mechanical&#xD;
             barrier (e.g. male condom, female diaphragm). The subject must be using this method&#xD;
             for at least 1 week following the end of the study or,&#xD;
&#xD;
             vi. Use of any intrauterine device (IUD) or contraceptive implant with published data&#xD;
             showing that the highest expected failure rate is less than 1% per year. The subject&#xD;
             must have the device inserted at least 2 weeks prior to the first Screen Visit,&#xD;
             throughout the study, and 2 weeks following the end of the study,&#xD;
&#xD;
          3. Are hypersensitive to any of the components of the test product,&#xD;
&#xD;
          4. Consumption of Alflorex probiotic for 6 months,&#xD;
&#xD;
          5. Consumption of any type of yoghurts or probiotic-containing products in the 4 weeks&#xD;
             prior to the baseline visit,&#xD;
&#xD;
          6. Subjects who have been on antibiotics during the past month,&#xD;
&#xD;
          7. Concurrent systemic disease and/or laboratory abnormalities considered by&#xD;
             Investigators to be risky or that could interfere with data collection,&#xD;
&#xD;
          8. Subjects who have a significant acute or chronic coexisting illness [cardiovascular,&#xD;
             history of co-existing gastrointestinal, and/or gynecological, and/or urologic&#xD;
             pathology (eg., colon cancer, colitis, Crohn's, celiac, endometriosis, prostate&#xD;
             cancer) or lactose intolerance,&#xD;
&#xD;
          9. Subjects with inflammatory disorders (e.g. chronic fatigue syndrome (CDC criteria),&#xD;
             psoriasis, rheumatoid arthritis or any other inflammatory arthropathies),&#xD;
&#xD;
         10. Subjects who are severely immunocompromised (HIV positive, transplant patient, on&#xD;
             antirejection medications, on a steroid for &gt;30 days, or chemotherapy or radiotherapy&#xD;
             within the last year),&#xD;
&#xD;
         11. Psychiatric diagnosis other than anxiety or depression,&#xD;
&#xD;
         12. Subjects who are on anti-depressants, anxiolytics, antipsychotics, anticonvulsants,&#xD;
             centrally acting corticosteroids and/or opioid pain relievers in the last 6 months,&#xD;
&#xD;
         13. Subject has IBS symptoms that are predominantly related to menstruation,&#xD;
&#xD;
         14. Subject has a history of prior gastrointestinal surgery (apart from appendectomy),&#xD;
&#xD;
         15. Subjects who have had a previous cholecystectomy,&#xD;
&#xD;
         16. Subjects with a history of active cancer in the last 5 years (other than localized&#xD;
             basal cell, squamous cell skin cancer or cancer in situ that has been resected),&#xD;
&#xD;
         17. Subjects with a history of drug and / or alcohol abuse at the time of enrolment,&#xD;
&#xD;
         18. Subject has a history of non-compliance,&#xD;
&#xD;
         19. Individuals who, in the opinion of the investigator, are considered to be poor&#xD;
             attendees or unlikely for any reason to be able to comply with the trial,&#xD;
&#xD;
         20. If the subject has been in a recent experimental trial, these must have been completed&#xD;
             not less than 30 days prior to this study,&#xD;
&#xD;
         21. Have a malignant disease or any concomitant end-stage organ disease.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eileen Murphy, PhD</last_name>
    <role>Study Director</role>
    <affiliation>PrecisionBiotics Group Ltd.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Atlantia Food Clinical Trials Ltd.</name>
      <address>
        <city>Cork</city>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Ireland</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>May 25, 2020</study_first_submitted>
  <study_first_submitted_qc>June 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>June 4, 2020</last_update_submitted>
  <last_update_submitted_qc>June 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Combination of probiotics</keyword>
  <keyword>Bifidobacterium longum 35624®</keyword>
  <keyword>Bifidobacterium longum 1714™</keyword>
  <keyword>depression</keyword>
  <keyword>anxiety</keyword>
  <keyword>bowel symptoms</keyword>
  <keyword>Irritable Bowel Syndrome (IBS)</keyword>
  <keyword>Sleep quality</keyword>
  <keyword>Cognition</keyword>
  <keyword>Safety</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Irritable Bowel Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
    <mesh_term>Depression</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04422327
org study id: AFCRO-079
nct id: NCT04422327
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study aimed to assess the impact of consumption of COMBO, a combination product of two
      Bifidobacterium longum strains, on stress, mood and bowel symptoms in adults with Irritable
      Bowel Syndrome (IBS).
This is an open label study designed to assess the impact on stress, mood and bowel symptoms
      & safety of COMBO, a combination of Bifidobacterium longum 35624® and Bifidobacterium longum
      1714™ strains, when consumed once daily for 8 weeks, in adults with Irritable Bowel Syndrome
      (IBS). Volunteers will be screened according to the selection criteria in order to identify
      up to 40 female subjects, with recurrent abdominal pain/discomfort and mild to moderate
      stress/mood status. The study will involve 6 visits over an 18 to 20-week period [Screening
      period (Visit 1: week-2), Intervention period (Visit 2: week 0, Visit 3: week 4, Visit 4:
      week 8), and Follow-up/ Washout period (Visit 5: week 12, Visit 6: week 16)]. Participants
      will fill in daily and weekly eDiary from 1st visit onwards. Questionnaires will be
      administered from visit 2 to visit 6. Research blood and saliva will also be collected at
      these time points. Stool sample will be collected at Visit 2, 4, 5, 6.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Open label study, with intervention period followed by follow-up (wash out) period.
primary purpose: Treatment
masking: None (Open Label)
measure: Change in stress and mood, assessed by Hospital Anxiety and Depression Scale (HADS) scores
time frame: Assessed at baseline, 4 and 8 weeks of supplement intake, and 4 and 8 weeks post supplement intake.
description: HADS gives HADS-A and HADS-D scores; minimum score for each is 0, maximum score is 21. Higher scores indicate worse stress/mood.
measure: Change in Subject Global Assessment (SGA) of IBS symptoms, assessed by weekly eDiary
time frame: Assessed weekly from baseline to 8 weeks post supplement intake.
description: Participants answer the question: "Did you have adequate relief of your IBS symptoms over the past week?" Yes or No.
measure: Change in Subject Global Assessment (SGA) of abdominal pain/discomfort, assessed by weekly eDiary
time frame: Assessed weekly from baseline to 8 weeks post supplement intake.
description: Participants answer the question: "Did you have adequate relief of your abdominal pain and discomfort over the past week?" Yes or No.
measure: Change in IBS-Symptom Severity Score (IBS-SSS)
time frame: Assessed at baseline, 4 and 8 weeks of supplement intake, and 4 and 8 weeks post supplement intake.
description: IBS-SSS is a composite score of abdominal pain, number of days with abdominal pain, bloating/distension, satisfaction with bowel habits, and IBS-related quality of life (QoL). Scores range from 0 to 500, with higher scores indicating worse symptoms.
measure: Change in stool frequency, assessed by daily eDiary
time frame: Assessed daily from baseline to 8 weeks post supplement intake.
description: Daily diary of number of bowel movements.
measure: Change in stool consistency (Bristol Stool Scale), assessed by daily eDiary
time frame: Assessed daily from baseline to 8 weeks post supplement intake.
description: Daily diary of stool consistency of each bowel movement based on Bristol Stool Scale (Type 1-7).
measure: Change in abdominal pain/discomfort, assessed by daily eDiary
time frame: Assessed daily from baseline to 8 weeks post supplement intake.
description: Daily diary of Visual Analog Scale (VAS) of abdominal pain/discomfort.
measure: Change in abdominal bloating/distension, assessed by daily eDiary
time frame: Assessed daily from baseline to 8 weeks post supplement intake.
description: Daily diary of Visual Analog Scale (VAS) of abdominal bloating/distension.
measure: Change in bowel movement urgency, assessed by daily eDiary
time frame: Assessed daily from baseline to 8 weeks post supplement intake.
description: Daily diary of Visual Analog Scale (VAS) of bowel movement urgency.
measure: Change in straining, assessed by daily eDiary
time frame: Assessed daily from baseline to 8 weeks post supplement intake.
description: Daily diary of Visual Analog Scale (VAS) of straining.
measure: Change in passage of gas, assessed by daily eDiary
time frame: Assessed daily from baseline to 8 weeks post supplement intake.
description: Daily diary of Visual Analog Scale (VAS) of passage of gas.
measure: Change in Visceral Sensitivity Index
time frame: Assessed at baseline, 4 and 8 weeks of supplement intake, and 4 and 8 weeks post supplement intake.
description: Visceral Sensitivity Index (VSI) is a self-report measure of the gastrointestinal symptom-specific anxiety (GSA) of patients with IBS, in terms of cognitive, emotional and behavioral responses. Sum scores range from 0 to 75 with higher scores indicating more severe GI-specific anxiety.
measure: Change in sleep quality, assessed by Pittsburgh Sleep Quality Index (PSQI)
time frame: Assessed at baseline, 4 and 8 weeks of supplement intake, and 4 and 8 weeks post supplement intake.
description: PSQI global score: minimum score is 0, maximum score is 21. Higher scores indicate worse sleep quality.
measure: Change in cognition, assessed by Visual Analogue Scales
time frame: Assessed at baseline, 4 and 8 weeks of supplement intake, and 4 and 8 weeks post supplement intake.
description: This assessment measures individual question answers related to hedonic tone, anxiety and alertness.
measure: Change in cognition, assessed by spatial span test
time frame: Assessed at baseline, 4 and 8 weeks of supplement intake, and 4 and 8 weeks post supplement intake.
description: This test measures span length, errors, number of attempts and latency.
measure: Change in cognition, assessed by Stockings of Cambridge test
time frame: Assessed at baseline, 4 and 8 weeks of supplement intake, and 4 and 8 weeks post supplement intake.
description: This test measures problems solved in minimum moves, mean moves per n-move problem, initial thinking time per n-move problems and subsequent thinking time per n-move problems.
measure: Change in cognition, assessed by Paired Associates Learning test
time frame: Assessed at baseline, 4 and 8 weeks of supplement intake, and 4 and 8 weeks post supplement intake.
description: This test measures errors, trials, memory scores and stages completed.
measure: Safety of the investigational product, assessed by number of participants with treatment-related adverse events
time frame: Assessed through study completion, an average of 6 months.
description: Safety will be evaluated throughout the study on the basis of incidence of treatment-related serious and non-serious adverse events.
arm group label: Probiotic capsule
arm group type: Experimental
description: The participants consume one probiotic capsule a day for 8 weeks
intervention type: Dietary Supplement
intervention name: Probiotic capsule
description: Each probiotic capsule contains 5 x 10^8 CFU B. longum 35624® and 5 x 10^8 CFU B. longum 1714™ with corn starch and magnesium stearate.
The probiotic capsule will be supplied by PrecisionBiotics Ltd.
arm group label: Probiotic capsule
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: No
last name: Eileen Murphy, PhD
role: Study Director
affiliation: PrecisionBiotics Group Ltd.
facility: 
country: Ireland
responsible party type: Sponsor
mesh term: Irritable Bowel Syndrome
mesh term: Syndrome
mesh term: Depression
sharing ipd: No