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

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. |
- 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
- 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
- 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
- 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
- Fecal inulin [ Time Frame: 48 hours ]Fecal inulin content will be measured using short acid hydrolysis and high-performance liquid chromatography
- 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.
- Stool characteristics [ Time Frame: 4 days ]Stool characteristics will be measured using a 4 day bowel diary

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.

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
Contact: Alka Kadariya | 317-278-9296 | akadariy@iu.edu | |
Contact: Anita Gupta | 317-948-9227 ext 3179489227 | anigupta@iu.edu |
United States, Indiana | |
Indiana University | Recruiting |
Indianapolis, Indiana, United States, 46202 | |
Contact: Alka Kadariya 317-278-9296 akadariy@iu.edu |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
microbiome microbiota short chain fatty acids prebiotic bile acids |
Irritable Bowel Syndrome Syndrome Disease Pathologic Processes Colonic Diseases, Functional |
Colonic Diseases Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases |