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Irritable Bowel Syndrome and Control Volunteers: Diet Challenge

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ClinicalTrials.gov Identifier: NCT03983434
Recruitment Status : Recruiting
First Posted : June 12, 2019
Last Update Posted : October 8, 2021
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Andrea Shin, Indiana University

Study Description
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Brief Summary:
The purpose of this study is to study the relationship between the bile acids, short chain fatty acids and bacteria within the intestines. The hypothesis is that changes in the bacterial composition of the stool are associated with the differences in bile acids and short chain fatty acids in patients having irritable bowel syndrome compared to healthy individuals.

Condition or disease Intervention/treatment Phase
IBS - Irritable Bowel Syndrome Dietary Supplement: Inulin Early Phase 1

Detailed Description:

The Study involves 3 visits and will in include 3 types of subjects - those who have irritable bowel syndrome (IBS) with constipation (IBS-C), IBS with diarrhea (IBS-D) and those who have no IBS symptoms or diagnosis.

Visit 1

  • Volunteers will read and sign this informed consent after all questions about the study have been answered
  • This is a screening visit and we may determine that volunteers ineligible to continue to participate in the study.
  • Volunteers will have a medical history taken including demographics, history of symptoms and illness
  • Volunteers will be asked about all medications
  • A physical exam will be performed by the physician.
  • Vital signs will be measured.
  • Urine Pregnancy test may be done for woman in the reproductive age range.
  • Eligible participants will be provided with a take-home lasagna meal.
  • Participants will be given instructions and supplies for collection, storage and transportation of stool for the next visit.
  • Participants will be provided with instructions for a low fiber, high fat diet which should be consumed for 2 days before stool collection and during the 2 days of stool collection. Instructions will also come with materials to allow participants to record diet intake during these 4 days.
  • Participants will be provided a bowel pattern diary to record bowel symptoms over the course of the study

Day 1: this may be the same as Visit 1 or it may be a different day. It will depend upon the day that participants can make it back to the clinic for the Day 5 visit.

Day 2-4 (at home):

  • Participants record stool symptoms and patterns in a diary daily starting from Day 2 to Day 5.
  • During this time, participants will be instructed to consume a low fiber diet, avoid alcohol, and start a 4-day 100 g fat diet.
  • On the evening before Day 5, a standardized, completely digestible, and non-fermentable meal (lasagna) will be consumed which will be provided to you on Day 1.
  • Participants will collect stool at home on Day 4 and 5 and store as per instructions provided on Visit 1. They will

Day 5 (Visit 2):

  • Participants return to the clinic on Day 5 after an overnight fast.
  • You will receive a standard breakfast and lasanga meal with 10 g inulin (Orafti®) powder and 200 mL of water.
  • Take-home meals will be provided (white bread sandwich with ham or cheese) to be consumed at 4 and 8 hours after breakfast.

Day 6 (Visit 3):

  • Participants will return to the clinic in order to return stool collections and the daily diaries.
  • Participants may also submit diaries by fax or email.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Fecal Bile Acids, Fecal Short Chain Fatty Acids and the Intestinal Microbiota in Patients With Irritable Bowel Syndrome (IBS) and Control Volunteers: Diet Challenge
Actual Study Start Date : August 13, 2019
Estimated Primary Completion Date : May 31, 2022
Estimated Study Completion Date : September 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement
Drug Information available for: Inulin

Arms and Interventions
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Arm Intervention/treatment
Experimental: Healthy volunteers
Adults ages 18-65 years with no prior history of gastrointestinal diseases or symptoms.
 Dietary Supplement: Inulin
Inulin ingestion is not being used to diagnose, treat, or prevent IBS. Inulin is being used to study an individual's ability to ferment dietary fiber.
Experimental: Irritable Bowel Syndrome Patients with Diarrhea
Patients with irritable bowel syndrome (IBS) with diarrhea, ages 18-65 years fulfilling Rome IV criteria for IBS
 Dietary Supplement: Inulin
Inulin ingestion is not being used to diagnose, treat, or prevent IBS. Inulin is being used to study an individual's ability to ferment dietary fiber.
Experimental: Irritable Bowel Syndrome Patients with Constipation
Patients with irritable bowel syndrome (IBS) with constipation, ages 18-65 years fulfilling Rome IV criteria for IBS
 Dietary Supplement: Inulin
Inulin ingestion is not being used to diagnose, treat, or prevent IBS. Inulin is being used to study an individual's ability to ferment dietary fiber.


Outcome Measures
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Primary Outcome Measures :
  1. Total fecal bile acids [ Time Frame: 48 hours ]
    Stool samples will be collected over 2 days for measurement of fecal bile acids (µmol/48h) by high performance liquid chromatography-mass spectometry

  2. Total fecal short chain fatty acids [ Time Frame: 48 hours ]
    Stool samples will be collected for measurement of measurement of short chain fatty acids (µg/mg) by liquid chromatography-mass spectrometry

  3. Individual fecal short chain fatty acids [ Time Frame: 48 hours ]
    Stool samples will be collected for measurement of measurement of short chain fatty acids (µg/mg) by liquid chromatography-mass spectrometry

  4. Fecal microbial population [ Time Frame: 48 hours ]
    Stool samples will be be collected from participants for nucleic acid extraction, 16S allele PCR and sequencing to measure microbial communities and profiles of specimens

  5. Fecal inulin [ Time Frame: 48 hours ]
    Fecal inulin content will be measured using short acid hydrolysis and high-performance liquid chromatography


Secondary Outcome Measures :
  1. Percent primary fecal bile acids [ Time Frame: 48 hours ]
    Stool samples will be collected over 2 days for measurement of fecal bile acids (µmol/48h) by high performance liquid chromatography-mass spectrometry.

  2. Stool characteristics [ Time Frame: 4 days ]
    Stool characteristics will be measured using a 4 day bowel diary


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients with IBS, ages 18-65 fulfilling Rome IV criteria and asymptomatic controls with no prior history of GI disease or symptoms.
  • Participants should be on a stable and consistent diet regimen and should not be following an extreme diet intervention such as gluten-free or a low FODMAP diet at the time of study participation.

Exclusion Criteria:

  • Participants with microscopic/lymphocytic/collagenous colitis, inflammatory bowel disease, celiac disease, visceral cancer, chronic infectious disease, immunodeficiency, uncontrolled thyroid disease, history of liver disease or history of elevated AST/ALT > 2.0x the upper limit of normal
  • Prior radiation therapy of the abdomen or abdominal surgeries except for C-section, tubal ligation, vaginal hysterectomy and appendectomy or cholecystectomy, > 6 months prior to study initiation.
  • Ingestion of any prescription, over the counter, or herbal medications which can affect GI transit or study interpretation (e.g. opioids, narcotics, anticholinergics, norepinephrine reuptake inhibitors, nonsteroidal anti-inflammatory drugs, COX-2 inhibitors, bile acid sequestrants) within 6 months of study initiation for asymptomatic volunteers or within 2 days before study initiation for IBS patients. Rescue therapy to facilitate stool collection will be permitted where needed.
  • Any females who are pregnant or trying to become pregnant or breast-feeding
  • Antibiotic usage within 3 months prior to study participation
  • Prebiotic or probiotic usage within the 2 weeks prior to study initiation
  • Regular use of tobacco products within the past 6 months.
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03983434


Contacts
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Contact: Alka Kadariya 317-278-9296 akadariy@iu.edu
Contact: Anita Gupta 317-948-9227 ext 3179489227 anigupta@iu.edu

Locations
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United States, Indiana
Indiana University Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Alka Kadariya    317-278-9296    akadariy@iu.edu   
Sponsors and Collaborators
Indiana University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
More Information
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Responsible Party: Andrea Shin, Assistant Professor, Indiana University
ClinicalTrials.gov Identifier: NCT03983434    
Other Study ID Numbers: 1903209172
K23DK122015 ( U.S. NIH Grant/Contract )
First Posted: June 12, 2019    Key Record Dates
Last Update Posted: October 8, 2021
Last Verified: October 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Andrea Shin, Indiana University:
microbiome
microbiota
short chain fatty acids
prebiotic
bile acids
Additional relevant MeSH terms:
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Irritable Bowel Syndrome
Syndrome
Disease
Pathologic Processes
Colonic Diseases, Functional
 Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases