- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03245645
FODMAP Reintroduction in Irritable Bowel Syndrome
Study Overview
Status
Intervention / Treatment
Detailed Description
Research supports clinical experience that ingestion of food often triggers the emergence or exacerbation of symptoms in the majority of patients with irritable bowel syndrome (IBS). While IBS remains primarily a symptom driven entity, our understanding of its pathophysiology is evolving. However, comparatively little research has focused on the specific role of certain foods and how they prompt the development of IBS symptoms.
Food may be linked to changes in motility, visceral sensation, gut microbiome, intestinal permeability, immune activation and brain-gut axis. This study will focus on fructose, which is one of the main components of FODMAP (fermentable oligosaccharides, disacharides, mono-saccharides and polyols) foods. Fructose is a common part of the Western diet and can be consumed as a free monosaccharide, part of sucrose, or in polymers referred to as fructans. There are no human gut specific fructose transporters. Rather glucose transporters are used (GLUT 2,5) leading some to hypothesize that over ingestion of these agents may trigger some of the enteric complaints of patients with IBS. The literature on fructose malabsorption gives varying threshold amounts: from 15 to 50 grams in healthy controls, and from 5 to 50 grams in IBS patients/known malabsorbers (Barrett, 2007; Rao, 2007; Frieling, 2011). Average daily fructose consumption in the American diet is approximately 34 grams, with a range of 15 to 54 grams, which falls well within the threshold levels (Frieling, 2011). FODMAP foods are thought to induce gastrointestinal symptoms including gas, bloating, abdominal pain or discomfort, and loose stools by increasing small bowel water content and increasing gas production by fermentation of foods by gut bacteria. Studies including a recent controlled clinical trial demonstrated that a low FODMAP diet can be an effective nutritional therapy.
There are risks to prolonged use of a low FODMAPs diet. A study from 2012 suggested that continued restriction of FODMAPS (longer than 4 weeks) can lead to reduction of luminal bifidobacteria in patients with IBS. Bifidobacteria mainly inhabit the large intestine where they produce short chain fatty acids (SCFA) as byproducts, including butyrate, shown to be important for colorectal cancer prevention and limit enteropathogenic colonization. Furthermore the diet is very restrictive and difficult for patients to maintain over time.
However, important clinical questions include when FODMAPS can be safely reintroduced into the diet, how quickly this can be accomplished, and what is a daily threshold of intake that is acceptable for IBS patients who respond or do not respond to a low FODMAPs diet. There are no evidence based answers to these questions, and it is in this setting that we propose our current project.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Los Angeles, California, United States, 90095
- UCLA
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adults (18+ years or older) with a diagnosis of IBS-D or IBS-M based on Rome IV criteria
- Diarrhea must occur 2 or more days per week
- Patients on current pharmacological therapy for their gastrointestinal complaints can enroll in the study as long as they have been on a stable dose for at least 30 days.
Exclusion Criteria:
- Significant comorbidities that are associated with GI symptoms (e.g. diabetes, scleroderma, SLE), history of GI surgery excluding appendectomy, or prior organic GI illness
- Antibiotics taken in the past 2 months
- Current disordered eating patterns (diagnosed eating disorder; as per verbal ESP questionnaire)
- Current history of greater than moderate alcohol intake (more than 1 drink per day for women, more than 2 drinks per day for men, binge drinking behavior of 5+ drinks in a single session once per week)
- Cannot have had a cholecystectomy in the past 6 months prior to enrollment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 100% Fructose
The fructose group will help to determine whether an absolute amount of fructose will lead to IBS symptoms.
|
Food may be linked to changes in motility, visceral sensation, gut microbiome, intestinal permeability, immune activation and brain-gut axis.
This study will focus on fructose, which is one of the main components of FODMAP (Fermentable oligosaccharides, dissacharides, mono-saccharides and polyols) foods.
Fructose is a common part of the Western diet and can be consumed as a free monosaccharide, part of sucrose, or in polymers referred to as fructans.
FODMAP foods are thought to induce gastrointestinal symptoms including gas, bloating, abdominal pain or discomfort, and loose stools by increasing small bowel water content and increasing gas production by fermentation of foods by gut bacteria.
Studies including a recent controlled clinical trial demonstrated that a low FODMAP diet can be an effective nutritional therapy.
|
Placebo Comparator: 100% Glucose
The glucose group will serve as a control since glucose is not a FODMAP and as a result is not expected to lead to recurrent symptoms.
|
Food may be linked to changes in motility, visceral sensation, gut microbiome, intestinal permeability, immune activation and brain-gut axis.
This study will focus on fructose, which is one of the main components of FODMAP (Fermentable oligosaccharides, dissacharides, mono-saccharides and polyols) foods.
Fructose is a common part of the Western diet and can be consumed as a free monosaccharide, part of sucrose, or in polymers referred to as fructans.
FODMAP foods are thought to induce gastrointestinal symptoms including gas, bloating, abdominal pain or discomfort, and loose stools by increasing small bowel water content and increasing gas production by fermentation of foods by gut bacteria.
Studies including a recent controlled clinical trial demonstrated that a low FODMAP diet can be an effective nutritional therapy.
|
Active Comparator: Fructose and Glucose
The glucose/fructose mixture group is a cross comparison group that will determine whether the relative excess fructose concentration is an important cause of IBS symptoms.
|
Food may be linked to changes in motility, visceral sensation, gut microbiome, intestinal permeability, immune activation and brain-gut axis.
This study will focus on fructose, which is one of the main components of FODMAP (Fermentable oligosaccharides, dissacharides, mono-saccharides and polyols) foods.
Fructose is a common part of the Western diet and can be consumed as a free monosaccharide, part of sucrose, or in polymers referred to as fructans.
FODMAP foods are thought to induce gastrointestinal symptoms including gas, bloating, abdominal pain or discomfort, and loose stools by increasing small bowel water content and increasing gas production by fermentation of foods by gut bacteria.
Studies including a recent controlled clinical trial demonstrated that a low FODMAP diet can be an effective nutritional therapy.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adequate relief of IBS symptoms in past 7 days
Time Frame: Baseline, 4 weeks (post-elimination diet)
|
As indicated by the study coordinator asking the participant "Have you had adequate relief of your IBS symptoms in the past 7 days?"
|
Baseline, 4 weeks (post-elimination diet)
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Highest amount of grams of sugar in solutions that do not significantly increase IBS symptoms
Time Frame: Daily, during weeks 5-7 (reintroduction phase)
|
As measured by 100 MM Visual Analog Scale (VAS) with 0 representing no symptoms for overall gastrointestinal symptoms.
|
Daily, during weeks 5-7 (reintroduction phase)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in IBS-symptom severity scale
Time Frame: Baseline, 4 weeks (post-elimination diet), 7 weeks (post-reintroduction phase)
|
This is a validated symptom questionnaire pertaining to irritable bowel syndrome symptoms
|
Baseline, 4 weeks (post-elimination diet), 7 weeks (post-reintroduction phase)
|
Change in Visceral Sensitivity Index (VSI)
Time Frame: Baseline, 4 weeks (post-elimination diet), 7 weeks (post-reintroduction phase)
|
This is a self-report measure of the gastrointestinal symptom-specific anxiety (GSA) of patients with irritable bowel syndrome (IBS)
|
Baseline, 4 weeks (post-elimination diet), 7 weeks (post-reintroduction phase)
|
Change in Personal Health Questionnaire (PHQ-15)
Time Frame: Baseline, 4 weeks (post-elimination diet), 7 weeks (post-reintroduction phase)
|
This is a validated symptom questionnaire pertaining to somatic symptoms severity
|
Baseline, 4 weeks (post-elimination diet), 7 weeks (post-reintroduction phase)
|
Change in abdominal pain severity
Time Frame: Baseline, 4 weeks (post-elimination diet), 7 weeks (post-reintroduction phase)
|
This is a self-report measure of the severity of abdominal pain during the week before report gathered by circling a number from 0-20 with 20 being the most intense pain imaginable.
|
Baseline, 4 weeks (post-elimination diet), 7 weeks (post-reintroduction phase)
|
Change in overall severity of gastrointestinal symptoms
Time Frame: Baseline, 4 weeks (post-elimination diet), 7 weeks (post-reintroduction phase)
|
This is a self-report measure of the overall severity of gastrointestinal symptoms during the week before report gathered by circling a number from 0-20 with 20 being the most intense symptoms imaginable.
|
Baseline, 4 weeks (post-elimination diet), 7 weeks (post-reintroduction phase)
|
Change in severity of the sensation of bloating, abdominal fullness or visible distension
Time Frame: Baseline, 4 weeks (post-elimination diet), 7 weeks (post-reintroduction phase)
|
This is a self-report measure of the severity of the sensation of bloating, abdominal fullness, or visible distension in the patient's belly that the patient has experienced during the week before report gathered by circling a number from 0-20 with 20 being the most intense sensation imaginable.
|
Baseline, 4 weeks (post-elimination diet), 7 weeks (post-reintroduction phase)
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Change in intestinal microbiota
Time Frame: Baseline, 4 weeks (post-elimination diet)
|
This is a measure of the intestinal microbiota 16S rRNA gene signatures in the patients' stool before and after the low FODMAP diet.
|
Baseline, 4 weeks (post-elimination diet)
|
Change in visceral sensitivity index score
Time Frame: Baseline, 4 weeks (post-elimination diet), 7 weeks (post-reintroduction phase)
|
This is a validated symptom questionnaire pertaining to gastrointestinal symptom related anxiety in patients with irritable bowel syndrome.
|
Baseline, 4 weeks (post-elimination diet), 7 weeks (post-reintroduction phase)
|
Collaborators and Investigators
Investigators
- Principal Investigator: Lin Chang, MD, University of California, Los Angeles
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16-000934
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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