<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/NCT02980406</url>
  </required_header>
  <id_info>
    <org_study_id>FODMAP1</org_study_id>
    <nct_id>NCT02980406</nct_id>
  </id_info>
  <brief_title>The Role of FODMAPs in Upper GI Effects, Colonic Motor Activity and Gut-brain Signaling at the Behavioral Level</brief_title>
  <official_title>The Role of FODMAPs in Upper GI Effects, Colonic Motor Activity and Gut-brain Signaling at the Behavioral Level</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universitaire Ziekenhuizen KU Leuven</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universitaire Ziekenhuizen KU Leuven</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this study, the investigators aim to assess the effect of acute FODMAP infusion on gastric&#xD;
      motility and on gastrointestinal and psychological symptoms. 20 healthy volunteers and 20&#xD;
      patients with irritable bowel syndrome (IBS) will undergo respectively four and two/three&#xD;
      pressure measurements of the stomach after an overnight fast as a measure for gastric&#xD;
      motility. During this pressure measurement, which takes approximately 4 hours, one of four&#xD;
      FODMAP or control solutions will be administered directly into the stomach through a&#xD;
      nasogastric tube. Administration will be stopped when the participant is fully satiated. The&#xD;
      four solutions that will be tested in healthy volunteers are (1) a fructan solution, (2) a&#xD;
      fructose solution, (3) a FODMAP mix and (4) a glucose solution as a control. In IBS patients,&#xD;
      only the fructan and glucose solution will be tested, where after they can choose to come for&#xD;
      a third visit to test the fructose solution. The solutions will be tested on separate&#xD;
      occasions in a randomized order.&#xD;
&#xD;
      During the pressure measurement, participants will be asked to complete several&#xD;
      questionnaires: (1) a gastrointestinal symptom questionnaire to assess their gastrointestinal&#xD;
      symptoms, (2) a satiation questionnaire during infusion of one of the solutions, (3)&#xD;
      psychological questionnaires (POMS, SAM, PANAS and STAI) to evaluate possible psychological&#xD;
      effects of FODMAP infusion.&#xD;
&#xD;
      The investigators hypothesize that there will be differences in gastric motility between&#xD;
      healthy volunteers and IBS patients. Furthermore, it is hypothesized that gastrointestinal&#xD;
      symptoms will be increased in IBS patients, and that FODMAP infusion will have more&#xD;
      psychological effects in patients than in healthy volunteers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this study, the investigators aim to assess the effect of acute FODMAP infusion on gastric&#xD;
      motility and on gastrointestinal and psychological symptoms. This is a randomised,&#xD;
      single-blinded, crossover study of different solutions, differing in FODMAP content. The four&#xD;
      solutions that will be tested in healthy volunteers are (1) a fructan solution, (2) a&#xD;
      fructose solution, (3) a FODMAP mix and (4) a glucose solution as a control. In IBS patients,&#xD;
      only the fructan and glucose solution will be tested, where after they can choose to come for&#xD;
      a third visit to test the fructose solution. The different solutions will be tested on&#xD;
      separate occasions, three days to one week apart, in a randomised order.&#xD;
&#xD;
      The preparation of each study visit will be identical. After an overnight fast, participants&#xD;
      will be asked to come to the clinic. To ensure a low baseline symptom level and low microbial&#xD;
      gut activity, a diet low in fibre and fermentable carbohydrates will be followed the day&#xD;
      prior to each test (information will be provided to assist this). Participants will be asked&#xD;
      to refrain from alcohol, tea and coffee, and intense physical activity for at least 12 hours&#xD;
      before participation. They will also be asked to refrain from smoking cigarettes at least one&#xD;
      hour before the start of the experiment.&#xD;
&#xD;
      A high resolution manometry probe will be inserted through the nose into the stomach of the&#xD;
      participant to assess intragastric pressure as a measure of gastric motility and gastric&#xD;
      accommodation. In addition, an infusion tube will be positioned in the proximal stomach to&#xD;
      administer the solution. The position of the probes will be checked fluoroscopically (maximum&#xD;
      15 seconds). In this case, relevant guidelines of radioprotection will be adhered to.&#xD;
      Patients will be protected by a lead shield that covers the lower abdomen and all personnel&#xD;
      will wear a lead jacket. After the catheters are fixed to the subjects' chin, the patients&#xD;
      will be asked to sit at a table and remain in this position for the remainder of the&#xD;
      experiment.&#xD;
&#xD;
      After a stabilization period of at least 15 minutes, and when the subject is in phase II of&#xD;
      the hunger cycle, one of four solutions will be intragastrically administered at a constant&#xD;
      speed of 60 mL per minute (determined by an automated system using a peristaltic pump). IGP&#xD;
      will be recorded for the duration of the drink infusion and for the following 3 hours. During&#xD;
      infusion, the subjects will be asked to score their satiation at 1-minute intervals using a&#xD;
      graphic rating scale that combines verbal descriptors on a scale graded of 0-5 (1, threshold;&#xD;
      5, maximum satiety). The intragastric infusion will be stopped as soon as a score of 5 is&#xD;
      reached on their satiation scores. In addition, participants will be asked to complete a&#xD;
      gastrointestinal symptom questionnaire every 15 minutes. The participant's emotions and mood&#xD;
      will be assessed before, immediately after and 1, 2 and 3 hours after infusion, using the&#xD;
      State-Trait Anxiety Inventory (STAI) and the validated Dutch version of the Positive and&#xD;
      Negative Affect Scale (PANAS). Emotional state will be repeatedly measured every 15 minutes&#xD;
      using the Self-Assessment Manikin (SAM) and Profile of Mood States (POMS)-Fatigue subscale.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2015</start_date>
  <completion_date type="Actual">June 2016</completion_date>
  <primary_completion_date type="Actual">June 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in intragastric pressure measured by high resolution manometry</measure>
    <time_frame>up to 3 hours after administration</time_frame>
    <description>Intragastric pressure will be assessed as a measure for gastric accommodation and gastric motility</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in subjective gastrointestinal symptom scores measured by visual analogue scale of 100 mm</measure>
    <time_frame>assessment by questionnaire (100 mm Visual Analogue Scale) every 15 minutes, up to 3 hours after administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in mood/emotion measured by Profile Of Mood States (POMS) questionnaire.</measure>
    <time_frame>POMS (Profile Of Mood States) every 15 minutes up to 3 hours after administration.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in mood/emotion measured by Self Assessment Manikin (SAM) questionnaire.</measure>
    <time_frame>SAM (Self Assessment Manikin) every 15 minutes up to 3 hours after administration.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in mood/emotion measured by Positive and Negative Affect Scale (PANAS).</measure>
    <time_frame>PANAS (Positive And Negative Affect Scale) before, after, 1h, 2h and 3h after administration.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in mood/emotion measured by State Trait Anxiety Index questionnaire.</measure>
    <time_frame>STAI (State Trait Anxiety) before, after, 1h, 2h and 3h after administration.</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Irritable Bowel Syndrome</condition>
  <arm_group>
    <arm_group_label>Fructans</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Fructans (FODMAP) are oligosaccharides containing fructose chains. Since the human body lacks hydrolases to break down these saccharides, fructans are poorly absorbed molecules in everybody. The fructan solution used in this study has a concentration of 38g/L.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fructose</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Fructose can be found in the diet as free fructose, in sucrose or as polymer structure in fructans. Absorption varies and occurs more rapidly in the presence of glucose than for free fructose because glucose cotransport is involved in the uptake of fructose. Therefore, when fructose is in excess of glucose, it is regarded as a FODMAP. The fructose concentration used in this study is 100g/L.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>FODMAP mix</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The FODMAP mix consists of 20g fructans, 10g galacto-oligosaccharides (GOS), 30g fructose, 10g sorbitol and 10g mannitol in one liter of tap water.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Glucose</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Glucose is a carbohydrate that is not classified as FODMAP, and is therefore used as a control in this study. The concentration of the glucose solution in this study is 100g/L.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>FODMAP</intervention_name>
    <description>Fermentable oligo-, di- and monosaccharides and polyols are poorly absorbed carbohydrates that are known to cause symptoms in IBS patients.</description>
    <arm_group_label>FODMAP mix</arm_group_label>
    <arm_group_label>Fructans</arm_group_label>
    <arm_group_label>Fructose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Glucose (control)</intervention_name>
    <description>Glucose is not a FODMAP.</description>
    <arm_group_label>Glucose</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Healthy volunteers:&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged between 18 to 65 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current symptoms or history of gastrointestinal disease, other significant diseases,&#xD;
             psychological disorders, drug allergies or pregnancy&#xD;
&#xD;
          -  Taking any medication or have any drug history&#xD;
&#xD;
        IBS patients:&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Meet Rome III criteria for IBS. This is defined as recurrent abdominal pain or&#xD;
             discomfort at least 3 days/month in the last 3 months associated with two or more of&#xD;
             the following: improvement with defecation; onset associated with a change in&#xD;
             frequency of stool; or onset associated with a change in form (appearance) of stool&#xD;
&#xD;
          -  Aged between 18 to 65 years old&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Other significant diseases, psychological disorder, drug allergies or pregnancy&#xD;
&#xD;
          -  Taking any non-steroidal anti-inflammatory drugs (NSAIDs), corticosteroids or other&#xD;
             immunosuppressive drugs in the preceding 6 months. All drugs potentially affecting&#xD;
             gastrointestinal motility or sensitivity will be discontinued at least 1 week before&#xD;
             the gastric emptying study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jan Tack, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UZ Leuven / KU Leuven</affiliation>
  </overall_official>
  <verification_date>May 2016</verification_date>
  <study_first_submitted>November 2, 2016</study_first_submitted>
  <study_first_submitted_qc>November 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 2, 2016</study_first_posted>
  <last_update_submitted>November 29, 2016</last_update_submitted>
  <last_update_submitted_qc>November 29, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 2, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>FODMAP</keyword>
  <keyword>Irritable bowel syndrome</keyword>
  <keyword>Gastric accommodation</keyword>
  <keyword>Gastric motility</keyword>
  <keyword>brain-gut axis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Irritable Bowel Syndrome</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/NCT02980406
org study id: FODMAP1
nct id: NCT02980406
lead sponsor: 
has dmc: No
In this study, the investigators aim to assess the effect of acute FODMAP infusion on gastric
      motility and on gastrointestinal and psychological symptoms. 20 healthy volunteers and 20
      patients with irritable bowel syndrome (IBS) will undergo respectively four and two/three
      pressure measurements of the stomach after an overnight fast as a measure for gastric
      motility. During this pressure measurement, which takes approximately 4 hours, one of four
      FODMAP or control solutions will be administered directly into the stomach through a
      nasogastric tube. Administration will be stopped when the participant is fully satiated. The
      four solutions that will be tested in healthy volunteers are (1) a fructan solution, (2) a
      fructose solution, (3) a FODMAP mix and (4) a glucose solution as a control. In IBS patients,
      only the fructan and glucose solution will be tested, where after they can choose to come for
      a third visit to test the fructose solution. The solutions will be tested on separate
      occasions in a randomized order.

      During the pressure measurement, participants will be asked to complete several
      questionnaires: (1) a gastrointestinal symptom questionnaire to assess their gastrointestinal
      symptoms, (2) a satiation questionnaire during infusion of one of the solutions, (3)
      psychological questionnaires (POMS, SAM, PANAS and STAI) to evaluate possible psychological
      effects of FODMAP infusion.

      The investigators hypothesize that there will be differences in gastric motility between
      healthy volunteers and IBS patients. Furthermore, it is hypothesized that gastrointestinal
      symptoms will be increased in IBS patients, and that FODMAP infusion will have more
      psychological effects in patients than in healthy volunteers.
In this study, the investigators aim to assess the effect of acute FODMAP infusion on gastric
      motility and on gastrointestinal and psychological symptoms. This is a randomised,
      single-blinded, crossover study of different solutions, differing in FODMAP content. The four
      solutions that will be tested in healthy volunteers are (1) a fructan solution, (2) a
      fructose solution, (3) a FODMAP mix and (4) a glucose solution as a control. In IBS patients,
      only the fructan and glucose solution will be tested, where after they can choose to come for
      a third visit to test the fructose solution. The different solutions will be tested on
      separate occasions, three days to one week apart, in a randomised order.

      The preparation of each study visit will be identical. After an overnight fast, participants
      will be asked to come to the clinic. To ensure a low baseline symptom level and low microbial
      gut activity, a diet low in fibre and fermentable carbohydrates will be followed the day
      prior to each test (information will be provided to assist this). Participants will be asked
      to refrain from alcohol, tea and coffee, and intense physical activity for at least 12 hours
      before participation. They will also be asked to refrain from smoking cigarettes at least one
      hour before the start of the experiment.

      A high resolution manometry probe will be inserted through the nose into the stomach of the
      participant to assess intragastric pressure as a measure of gastric motility and gastric
      accommodation. In addition, an infusion tube will be positioned in the proximal stomach to
      administer the solution. The position of the probes will be checked fluoroscopically (maximum
      15 seconds). In this case, relevant guidelines of radioprotection will be adhered to.
      Patients will be protected by a lead shield that covers the lower abdomen and all personnel
      will wear a lead jacket. After the catheters are fixed to the subjects' chin, the patients
      will be asked to sit at a table and remain in this position for the remainder of the
      experiment.

      After a stabilization period of at least 15 minutes, and when the subject is in phase II of
      the hunger cycle, one of four solutions will be intragastrically administered at a constant
      speed of 60 mL per minute (determined by an automated system using a peristaltic pump). IGP
      will be recorded for the duration of the drink infusion and for the following 3 hours. During
      infusion, the subjects will be asked to score their satiation at 1-minute intervals using a
      graphic rating scale that combines verbal descriptors on a scale graded of 0-5 (1, threshold;
      5, maximum satiety). The intragastric infusion will be stopped as soon as a score of 5 is
      reached on their satiation scores. In addition, participants will be asked to complete a
      gastrointestinal symptom questionnaire every 15 minutes. The participant's emotions and mood
      will be assessed before, immediately after and 1, 2 and 3 hours after infusion, using the
      State-Trait Anxiety Inventory (STAI) and the validated Dutch version of the Positive and
      Negative Affect Scale (PANAS). Emotional state will be repeatedly measured every 15 minutes
      using the Self-Assessment Manikin (SAM) and Profile of Mood States (POMS)-Fatigue subscale.
allocation: Randomized
intervention model: Crossover Assignment
masking: Single (Participant)
measure: Change in intragastric pressure measured by high resolution manometry
time frame: up to 3 hours after administration
description: Intragastric pressure will be assessed as a measure for gastric accommodation and gastric motility
measure: Change in subjective gastrointestinal symptom scores measured by visual analogue scale of 100 mm
time frame: assessment by questionnaire (100 mm Visual Analogue Scale) every 15 minutes, up to 3 hours after administration
measure: Change in mood/emotion measured by Profile Of Mood States (POMS) questionnaire.
time frame: POMS (Profile Of Mood States) every 15 minutes up to 3 hours after administration.
measure: Change in mood/emotion measured by Self Assessment Manikin (SAM) questionnaire.
time frame: SAM (Self Assessment Manikin) every 15 minutes up to 3 hours after administration.
measure: Change in mood/emotion measured by Positive and Negative Affect Scale (PANAS).
time frame: PANAS (Positive And Negative Affect Scale) before, after, 1h, 2h and 3h after administration.
measure: Change in mood/emotion measured by State Trait Anxiety Index questionnaire.
time frame: STAI (State Trait Anxiety) before, after, 1h, 2h and 3h after administration.
arm group label: Fructans
arm group type: Active Comparator
description: Fructans (FODMAP) are oligosaccharides containing fructose chains. Since the human body lacks hydrolases to break down these saccharides, fructans are poorly absorbed molecules in everybody. The fructan solution used in this study has a concentration of 38g/L.
arm group label: Fructose
arm group type: Active Comparator
description: Fructose can be found in the diet as free fructose, in sucrose or as polymer structure in fructans. Absorption varies and occurs more rapidly in the presence of glucose than for free fructose because glucose cotransport is involved in the uptake of fructose. Therefore, when fructose is in excess of glucose, it is regarded as a FODMAP. The fructose concentration used in this study is 100g/L.
arm group label: FODMAP mix
arm group type: Active Comparator
description: The FODMAP mix consists of 20g fructans, 10g galacto-oligosaccharides (GOS), 30g fructose, 10g sorbitol and 10g mannitol in one liter of tap water.
arm group label: Glucose
arm group type: Placebo Comparator
description: Glucose is a carbohydrate that is not classified as FODMAP, and is therefore used as a control in this study. The concentration of the glucose solution in this study is 100g/L.
intervention type: Dietary Supplement
intervention name: FODMAP
description: Fermentable oligo-, di- and monosaccharides and polyols are poorly absorbed carbohydrates that are known to cause symptoms in IBS patients.
arm group label: FODMAP mix
arm group label: Fructans
arm group label: Fructose
intervention type: Dietary Supplement
intervention name: Glucose (control)
description: Glucose is not a FODMAP.
arm group label: Glucose
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jan Tack, MD, PhD
role: Principal Investigator
affiliation: UZ Leuven / KU Leuven
responsible party type: Sponsor
mesh term: Irritable Bowel Syndrome
sharing ipd: No