xml: <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/NCT05978973</url>
    </required_header>
    <id_info>
      <org_study_id>STUDY00002455:</org_study_id>
      <nct_id>NCT05978973</nct_id>
    </id_info>
    <brief_title>Elemental Diet and Gut Microbiome</brief_title>
    <official_title>Elemental Diet and Gut Microbiome</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Cedars-Sinai Medical Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Cedars-Sinai Medical Center</source>
    <oversight_info>
      <has_dmc>No</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>
        he primary objective of this study is to assess changes in stool microbiome profiles in&#xD;
        patients after an elemental diet.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The gut microbiome is the collection of microbes residing inside the gastrointestinal (GI)&#xD;
        tract. The involvement of the gut microbiome has been demonstrated in multiple diseases&#xD;
        processes including irritable bowel syndrome, small intestinal bacterial overgrowth (SIBO),&#xD;
        Crohn's disease, and ulcerative colitis among many other diseases. A &quot;healthy&quot; diverse gut&#xD;
        microbiome is associated with a better response to infections and immunopathogenic insults.&#xD;
  &#xD;
        Many factors can affect the gut microbiome including medications, age, disease states and&#xD;
        diet. Among these factors, diet is the easiest factor that can be modified to improve the gut&#xD;
        microbiome. However, conducting dietary trials is challenging due to the inability to fully&#xD;
        standardize what subjects eat even with strict dietary instructions. Moreover, individual&#xD;
        preferences/allergies, the source of dietary ingredients, freshness, and food preparation are&#xD;
        important steps which affect the diet and are challenging to standardize among subjects in a&#xD;
        diet trial. This has led to significant ambiguity regarding the true extent and depth of&#xD;
        dietary modifications on gut microbiome.&#xD;
  &#xD;
        Apart from vitamins and micronutrients, the three main food macronutrients in the human diet&#xD;
        are carbohydrates, protein and fat. Upon digestion, carbohydrates are broken into&#xD;
        monosaccharides, proteins into amino acids and fats mainly into fatty acids. Elemental diets&#xD;
        contain all daily required vitamins, micronutrients and macronutrients. The ingredients are&#xD;
        readily digestible (carbohydrates, amino acids and medium chain fatty acids) and are absorbed&#xD;
        within the proximal small bowel. One main disadvantage of elemental diets such as Vivonex is&#xD;
        their unpalatability which has limited their use. A palatable elemental diet can be a very&#xD;
        valuable tool to enable us to assess the effects of diet on the gut microbiome as it bypasses&#xD;
        several confounding effects in dietary trials such as food allergies, individual digestion&#xD;
        variability, completeness of the diet ingredients, and food preparation.&#xD;
  &#xD;
        SIBO is a condition in which the gut microbiome plays an integral role and is defined by&#xD;
        abnormal and excessive numbers of bacteria in the small bowel.4 Interest in SIBO has been&#xD;
        fueled by the ever-increasing awareness of the human microbiome and its potential&#xD;
        relationships to human health and disease. SIBO is a preferred condition to assess the&#xD;
        effects of elemental diet on the gut microbiome, given the known role of the gut microbiome&#xD;
        in SIBO. Those with SIBO experience a range of intestinal and extraintestinal symptoms&#xD;
        including diarrhea, nausea, bloating, abdominal pain, and excess gas.&#xD;
  &#xD;
        Commonly, SIBO has been defined by two methods: direct culture of small bowel aspirates, and&#xD;
        indirect assessment using carbohydrate (e.g. lactulose or glucose) breath testing. SIBO is&#xD;
        generally treated with antibiotics. Low fermentable and elemental diets also have positive&#xD;
        effects in SIBO. Based on the potential effects of diet on the gut microbiome, we hypothesize&#xD;
        that a two-week period of an elemental diet can change the gut microbiome in SIBO subjects.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 6, 2023</start_date>
    <completion_date type="Anticipated">June 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">August 1, 2024</primary_completion_date>
    <phase>N/A</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>
      <primary_purpose>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>assess changes in stool microbiome profiles</measure>
      <time_frame>28 DAYS</time_frame>
      <description>is to assess changes in stool microbiome profiles in patients after an elemental diet, as determined by 16S rRNA gene sequencing • Microbiome profiles will be determined in stool samples provided on visit 2 (day 0), visit 4 (day 14) and visit 6 (day 28). These analyses will be performed in batch at the end of the study and the profiles at visit 4 (day 14) and visit 6 (day 28) will be compared to those at visit 2 (day 0).</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Irritable Bowel Syndrome</condition>
    <arm_group>
      <arm_group_label>elemental diet</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>subjects will be using the elemental diet packets daily. Subjects who are positive for excessive methane (i.e. methane level&gt;10 ppm) will be required to complete a single daily fasting methane measurement (SMM) for the duration of the 14 days.</description>
    </arm_group>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Elemental Diet</intervention_name>
      <description>. Elemental diets contain all daily required vitamins, micronutrients and macronutrients. The ingredients are readily digestible (carbohydrates, amino acids and medium chain fatty acids) and are absorbed within the proximal small bowel. One main disadvantage of elemental diets such as Vivonex is their unpalatability3 which has limited their use.</description>
      <arm_group_label>elemental diet</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  • Participant must be able to understand and provide informed consent&#xD;
  &#xD;
                 -  Males and Females ≥18-85&#xD;
  &#xD;
                 -  Female subjects of childbearing potential must have a negative pregnancy test&#xD;
                    upon study entry&#xD;
  &#xD;
                 -  Female (and male) subjects with reproductive potential, must agree to use FDA&#xD;
                    approved methods of birth control for the duration of the study&#xD;
  &#xD;
                 -  Subject self-reports experiencing SIBO symptoms within 30 days&#xD;
  &#xD;
                 -  Positive (abnormal) lactulose breath test for SIBO on visit 1 (day -7) as defined&#xD;
                    as:&#xD;
  &#xD;
                      -  Rise of hydrogen ≥ 20ppm within 90 minutes on LBT OR&#xD;
  &#xD;
                      -  A methane level ≥10 ppm at any point during the 120-minute LBT&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  • Inability or unwillingness of a participant to give written informed consent or&#xD;
               comply with study protocol&#xD;
  &#xD;
                 -  Pregnancy or lactating&#xD;
  &#xD;
                 -  Type 1 or type 2 diabetes&#xD;
  &#xD;
                 -  Active or ongoing infection that requires antibiotics other than the participants&#xD;
                    known prophylactic medications (i.e. active infection or antibiotic use in the&#xD;
                    last 1 month)&#xD;
  &#xD;
                 -  Any condition that, in the opinion of the investigator, contraindicates&#xD;
                    participation in this study will be excluded from study participation.&#xD;
  &#xD;
                 -  History of known Phenylketonuria (PKU) disease&#xD;
  &#xD;
                 -  Non-English-speaking participants&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>85 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Bianca Chang, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Cedars-Sinai Medical Center</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>MAST Program</last_name>
      <phone>(310) 423-0617</phone>
      <email>mastprogram@cshs.org</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Mohamad Rashid</last_name>
      <phone>(310) 423-0617</phone>
      <email>mastprogram@cshs.org</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Cedars-Sinai Medical Center</name>
        <address>
          <city>Los Angeles</city>
          <state>California</state>
          <zip>90048</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <reference>
      <citation>Pimentel M, Mathur R, Wang J, Chang C, Hosseini A, Fiorentino A, Rashid M, Pichetshote N, Basseri B, Treyzon L, Chang B, Leite G, Morales W, Weitsman S, Kraus A, Rezaie A. A Smartphone Application Using Artificial Intelligence Is Superior To Subject Self-Reporting When Assessing Stool Form. Am J Gastroenterol. 2022 Jul 1;117(7):1118-1124. doi: 10.14309/ajg.0000000000001723. Epub 2022 Mar 14.</citation>
      <PMID>35288511</PMID>
    </reference>
    <reference>
      <citation>Wu X, Zhu Y, Yang M, Zhang J, Lin D. Biological responses of Eisenia fetida towards the exposure and metabolism of tris (2-butoxyethyl) phosphate. Sci Total Environ. 2022 Mar 10;811:152285. doi: 10.1016/j.scitotenv.2021.152285. Epub 2021 Dec 18.</citation>
      <PMID>34933047</PMID>
    </reference>
    <reference>
      <citation>Moore DA, Schatz D. Overprecision increases subsequent surprise. PLoS One. 2020 Jul 8;15(7):e0227084. doi: 10.1371/journal.pone.0227084. eCollection 2020.</citation>
      <PMID>32639957</PMID>
    </reference>
    <reference>
      <citation>Kilic E, Tennstedt P, Hogner A, Lebok P, Sauter G, Bokemeyer C, Izbicki JR, Wilczak W. The zinc-finger transcription factor SALL4 is frequently expressed in human cancers: association with clinical outcome in squamous cell carcinoma but not in adenocarcinoma of the esophagus. Virchows Arch. 2016 Apr;468(4):483-92. doi: 10.1007/s00428-016-1908-y. Epub 2016 Jan 27.</citation>
      <PMID>26818834</PMID>
    </reference>
    <reference>
      <citation>Rubin R. Botulinum Toxin to Treat Endometriosis Pain. JAMA. 2019 Aug 27;322(8):716. doi: 10.1001/jama.2019.12350. No abstract available.</citation>
      <PMID>31454029</PMID>
    </reference>
    <reference>
      <citation>Rotovnik Kozjek N, Kompan L, Zagar T, Mrevlje Z. Influence of enteral glutamine on inflammatory and hormonal response in patients with rectal cancer during preoperative radiochemotherapy. Eur J Clin Nutr. 2017 May;71(5):671-673. doi: 10.1038/ejcn.2017.11. Epub 2017 Mar 8.</citation>
      <PMID>28272402</PMID>
    </reference>
    <reference>
      <citation>Pimentel M, Constantino T, Kong Y, Bajwa M, Rezaei A, Park S. A 14-day elemental diet is highly effective in normalizing the lactulose breath test. Dig Dis Sci. 2004 Jan;49(1):73-7. doi: 10.1023/b:ddas.0000011605.43979.e1.</citation>
      <PMID>14992438</PMID>
    </reference>
    <reference>
      <citation>Gombert A, Van Herzeele I. We Want to OPERATE! Eur J Vasc Endovasc Surg. 2020 May;59(5):775. doi: 10.1016/j.ejvs.2020.01.033. Epub 2020 Feb 20. No abstract available.</citation>
      <PMID>32088068</PMID>
    </reference>
    <reference>
      <citation>Speller B, Metcalfe K, Kennedy ED, Facey M, Greenblatt E, Scheer AS, Warner E, Joy AA, Wright FC, Baxter NN. The &quot;Begin Exploring Fertility Options, Risks and Expectations&quot; (BEFORE) decision aid: development and alpha testing of a fertility tool for premenopausal breast cancer patients. BMC Med Inform Decis Mak. 2019 Oct 28;19(1):203. doi: 10.1186/s12911-019-0912-y.</citation>
      <PMID>31660965</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 30, 2023</study_first_submitted>
    <study_first_submitted_qc>July 30, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>August 8, 2023</last_update_submitted>
    <last_update_submitted_qc>August 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Cedars-Sinai Medical Center</investigator_affiliation>
      <investigator_full_name>Bianca Chang</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <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>
  
  
text: 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/NCT05978973
  org study id: STUDY00002455:
  nct id: NCT05978973
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  he primary objective of this study is to assess changes in stool microbiome profiles in
        patients after an elemental diet.
  The gut microbiome is the collection of microbes residing inside the gastrointestinal (GI)
        tract. The involvement of the gut microbiome has been demonstrated in multiple diseases
        processes including irritable bowel syndrome, small intestinal bacterial overgrowth (SIBO),
        Crohn's disease, and ulcerative colitis among many other diseases. A "healthy" diverse gut
        microbiome is associated with a better response to infections and immunopathogenic insults.
  
        Many factors can affect the gut microbiome including medications, age, disease states and
        diet. Among these factors, diet is the easiest factor that can be modified to improve the gut
        microbiome. However, conducting dietary trials is challenging due to the inability to fully
        standardize what subjects eat even with strict dietary instructions. Moreover, individual
        preferences/allergies, the source of dietary ingredients, freshness, and food preparation are
        important steps which affect the diet and are challenging to standardize among subjects in a
        diet trial. This has led to significant ambiguity regarding the true extent and depth of
        dietary modifications on gut microbiome.
  
        Apart from vitamins and micronutrients, the three main food macronutrients in the human diet
        are carbohydrates, protein and fat. Upon digestion, carbohydrates are broken into
        monosaccharides, proteins into amino acids and fats mainly into fatty acids. Elemental diets
        contain all daily required vitamins, micronutrients and macronutrients. The ingredients are
        readily digestible (carbohydrates, amino acids and medium chain fatty acids) and are absorbed
        within the proximal small bowel. One main disadvantage of elemental diets such as Vivonex is
        their unpalatability which has limited their use. A palatable elemental diet can be a very
        valuable tool to enable us to assess the effects of diet on the gut microbiome as it bypasses
        several confounding effects in dietary trials such as food allergies, individual digestion
        variability, completeness of the diet ingredients, and food preparation.
  
        SIBO is a condition in which the gut microbiome plays an integral role and is defined by
        abnormal and excessive numbers of bacteria in the small bowel.4 Interest in SIBO has been
        fueled by the ever-increasing awareness of the human microbiome and its potential
        relationships to human health and disease. SIBO is a preferred condition to assess the
        effects of elemental diet on the gut microbiome, given the known role of the gut microbiome
        in SIBO. Those with SIBO experience a range of intestinal and extraintestinal symptoms
        including diarrhea, nausea, bloating, abdominal pain, and excess gas.
  
        Commonly, SIBO has been defined by two methods: direct culture of small bowel aspirates, and
        indirect assessment using carbohydrate (e.g. lactulose or glucose) breath testing. SIBO is
        generally treated with antibiotics. Low fermentable and elemental diets also have positive
        effects in SIBO. Based on the potential effects of diet on the gut microbiome, we hypothesize
        that a two-week period of an elemental diet can change the gut microbiome in SIBO subjects.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Other
  masking: None (Open Label)
  measure: assess changes in stool microbiome profiles
  time frame: 28 DAYS
  description: is to assess changes in stool microbiome profiles in patients after an elemental diet, as determined by 16S rRNA gene sequencing • Microbiome profiles will be determined in stool samples provided on visit 2 (day 0), visit 4 (day 14) and visit 6 (day 28). These analyses will be performed in batch at the end of the study and the profiles at visit 4 (day 14) and visit 6 (day 28) will be compared to those at visit 2 (day 0).
  arm group label: elemental diet
  arm group type: Experimental
  description: subjects will be using the elemental diet packets daily. Subjects who are positive for excessive methane (i.e. methane level>10 ppm) will be required to complete a single daily fasting methane measurement (SMM) for the duration of the 14 days.
  intervention type: Dietary Supplement
  intervention name: Elemental Diet
  description: . Elemental diets contain all daily required vitamins, micronutrients and macronutrients. The ingredients are readily digestible (carbohydrates, amino acids and medium chain fatty acids) and are absorbed within the proximal small bowel. One main disadvantage of elemental diets such as Vivonex is their unpalatability3 which has limited their use.
  arm group label: elemental diet
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 85 Years
  healthy volunteers: No
  last name: Bianca Chang, MD
  role: Principal Investigator
  affiliation: Cedars-Sinai Medical Center
  last name: MAST Program
  phone: (310) 423-0617
  email: mastprogram@cshs.org
  last name: Mohamad Rashid
  phone: (310) 423-0617
  email: mastprogram@cshs.org
  facility: 
  status: Recruiting
  country: United States
  citation: Pimentel M, Mathur R, Wang J, Chang C, Hosseini A, Fiorentino A, Rashid M, Pichetshote N, Basseri B, Treyzon L, Chang B, Leite G, Morales W, Weitsman S, Kraus A, Rezaie A. A Smartphone Application Using Artificial Intelligence Is Superior To Subject Self-Reporting When Assessing Stool Form. Am J Gastroenterol. 2022 Jul 1;117(7):1118-1124. doi: 10.14309/ajg.0000000000001723. Epub 2022 Mar 14.
  PMID: 35288511
  citation: Wu X, Zhu Y, Yang M, Zhang J, Lin D. Biological responses of Eisenia fetida towards the exposure and metabolism of tris (2-butoxyethyl) phosphate. Sci Total Environ. 2022 Mar 10;811:152285. doi: 10.1016/j.scitotenv.2021.152285. Epub 2021 Dec 18.
  PMID: 34933047
  citation: Moore DA, Schatz D. Overprecision increases subsequent surprise. PLoS One. 2020 Jul 8;15(7):e0227084. doi: 10.1371/journal.pone.0227084. eCollection 2020.
  PMID: 32639957
  citation: Kilic E, Tennstedt P, Hogner A, Lebok P, Sauter G, Bokemeyer C, Izbicki JR, Wilczak W. The zinc-finger transcription factor SALL4 is frequently expressed in human cancers: association with clinical outcome in squamous cell carcinoma but not in adenocarcinoma of the esophagus. Virchows Arch. 2016 Apr;468(4):483-92. doi: 10.1007/s00428-016-1908-y. Epub 2016 Jan 27.
  PMID: 26818834
  citation: Rubin R. Botulinum Toxin to Treat Endometriosis Pain. JAMA. 2019 Aug 27;322(8):716. doi: 10.1001/jama.2019.12350. No abstract available.
  PMID: 31454029
  citation: Rotovnik Kozjek N, Kompan L, Zagar T, Mrevlje Z. Influence of enteral glutamine on inflammatory and hormonal response in patients with rectal cancer during preoperative radiochemotherapy. Eur J Clin Nutr. 2017 May;71(5):671-673. doi: 10.1038/ejcn.2017.11. Epub 2017 Mar 8.
  PMID: 28272402
  citation: Pimentel M, Constantino T, Kong Y, Bajwa M, Rezaei A, Park S. A 14-day elemental diet is highly effective in normalizing the lactulose breath test. Dig Dis Sci. 2004 Jan;49(1):73-7. doi: 10.1023/b:ddas.0000011605.43979.e1.
  PMID: 14992438
  citation: Gombert A, Van Herzeele I. We Want to OPERATE! Eur J Vasc Endovasc Surg. 2020 May;59(5):775. doi: 10.1016/j.ejvs.2020.01.033. Epub 2020 Feb 20. No abstract available.
  PMID: 32088068
  citation: Speller B, Metcalfe K, Kennedy ED, Facey M, Greenblatt E, Scheer AS, Warner E, Joy AA, Wright FC, Baxter NN. The "Begin Exploring Fertility Options, Risks and Expectations" (BEFORE) decision aid: development and alpha testing of a fertility tool for premenopausal breast cancer patients. BMC Med Inform Decis Mak. 2019 Oct 28;19(1):203. doi: 10.1186/s12911-019-0912-y.
  PMID: 31660965
  responsible party type: Principal Investigator
  investigator affiliation: Cedars-Sinai Medical Center
  investigator full name: Bianca Chang
  investigator title: Principal Investigator
  mesh term: Irritable Bowel Syndrome
  sharing ipd: No