Irritable Bowel Syndrome With DiarrheaNCT03245645
FODMAP Reintroduction in Irritable Bowel Syndrome
A study testing Dietary Intervention in people with Irritable Bowel Syndrome With Diarrhea and Irritable Bowel Syndrome With Mixed Bowel Habits, run by University of California, Los Angeles at 1 site in United States.
Trial summary
The purpose of this study is to determine the amount and timing of when certain Fermentable Oligo-Di-Monosaccharides and Polyols (FODMAPs), specifically fructose, can be safely reintroduced into the diet of Irritable Bowel Syndrome (IBS) patients that have successfully completed a low-FODMAP elimination diet. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Irritable Bowel Syndrome With Diarrhea, Irritable Bowel Syndrome With Mixed Bowel Habits
- What is being tested?
- Dietary Intervention
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Mar 2017to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine the amount and timing of when certain Fermentable Oligo-Di-Monosaccharides and Polyols (FODMAPs), specifically fructose, can be safely reintroduced into the diet of Irritable Bowel Syndrome (IBS) patients that have successfully completed a low-FODMAP elimination diet. The FODMAP diet is an effective treatment for IBS; however it is unclear how patients can successfully reintroduce and liberalize fructose into their diet. The low FODMAP diet is thought to reduce IBS symptoms by decreasing water content and gas production in the bowel and also possibly by altering gut bacteria. Although use of the FODMAP elimination diet can initially successfully treat IBS symptoms for up to 50-75% of patients, the reintroduction diet is difficult for patients to complete and maintain for long periods of time because current methods for reintroduction of FODMAPs are imprecise leading to frequent recurrent symptoms. As a result, patients often continue the low FODMAP elimination diet for additional months because they have difficulties knowing how to add back FODMAPs into their diet. There are no studies to date to help guide patients with FODMAP reintroduction.
Read the 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.
- Being tested
- Dietary Intervention
- Keywords
- FODMAP, IBS, Diet, Re-introduction, Fructose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary InterventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 100% Fructose | Experimental | The fructose group will help to determine whether an absolute amount of fructose will lead to IBS symptoms. Receives: Other: Dietary Intervention |
| 100% Glucose | Placebo comparator | 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. Receives: Other: Dietary Intervention |
| Fructose and Glucose | Active comparator | 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. Receives: Other: Dietary Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adequate relief of IBS symptoms in past 7 days
As indicated by the study coordinator asking the participant "Have you had adequate relief of your IBS symptoms in the past 7 days?"
Measured: Baseline, 4 weeks (post-elimination diet)
Highest amount of grams of sugar in solutions that do not significantly increase IBS symptoms
As measured by 100 MM Visual Analog Scale (VAS) with 0 representing no symptoms for overall gastrointestinal symptoms.
Measured: Daily, during weeks 5-7 (reintroduction phase)
Secondary outcomes (8)
Change in IBS-symptom severity scale
This is a validated symptom questionnaire pertaining to irritable bowel syndrome symptoms
Measured: Baseline, 4 weeks (post-elimination diet), 7 weeks (post-reintroduction phase)
Change in Visceral Sensitivity Index (VSI)
This is a self-report measure of the gastrointestinal symptom-specific anxiety (GSA) of patients with irritable bowel syndrome (IBS)
Measured: Baseline, 4 weeks (post-elimination diet), 7 weeks (post-reintroduction phase)
Change in Personal Health Questionnaire (PHQ-15)
This is a validated symptom questionnaire pertaining to somatic symptoms severity
Measured: Baseline, 4 weeks (post-elimination diet), 7 weeks (post-reintroduction phase)
Change in abdominal pain severity
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.
Measured: Baseline, 4 weeks (post-elimination diet), 7 weeks (post-reintroduction phase)
Change in overall severity of gastrointestinal symptoms
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.
Measured: Baseline, 4 weeks (post-elimination diet), 7 weeks (post-reintroduction phase)
Change in severity of the sensation of bloating, abdominal fullness or visible distension
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.
Measured: Baseline, 4 weeks (post-elimination diet), 7 weeks (post-reintroduction phase)
Change in intestinal microbiota
This is a measure of the intestinal microbiota 16S rRNA gene signatures in the patients' stool before and after the low FODMAP diet.
Measured: Baseline, 4 weeks (post-elimination diet)
Change in visceral sensitivity index score
This is a validated symptom questionnaire pertaining to gastrointestinal symptom related anxiety in patients with irritable bowel syndrome.
Measured: Baseline, 4 weeks (post-elimination diet), 7 weeks (post-reintroduction phase)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2017
- Study start24 Mar 2017
- Primary completion30 Jun 2021
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel Syndrome With DiarrheaStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lin Chang, MD, University of California, Los Angeles
- Investigators
- Lin Chang, MD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03245645
- Sponsor's protocol ID
- 16-000934
- Status last verified
- Jul 2023
- First submitted
- 25 Jul 2017
- Last updated
- 11 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FODMAP Reintroduction in Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT03245645
- Acronym / sponsor ID
- 16-000934
- Keywords
- FODMAP, IBS, Diet, Re-introduction, Fructose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 24 Mar 2017 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 10 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the amount and timing of when certain Fermentable Oligo-Di-Monosaccharides and Polyols (FODMAPs), specifically fructose, can be safely reintroduced into the diet of Irritable Bowel Syndrome (IBS) patients that have successfully completed a low-FODMAP elimination diet. The FODMAP diet is an effective treatment for IBS; however it is unclear how patients can successfully reintroduce and liberalize fructose into their diet. The low FODMAP diet is thought to reduce IBS symptoms by decreasing water content and gas production in the bowel and also possibly by altering gut bacteria. Although use of the FODMAP elimination diet can initially successfully treat IBS symptoms for up to 50-75% of patients, the reintroduction diet is difficult for patients to complete and maintain for long periods of time because current methods for reintroduction of FODMAPs are imprecise leading to frequent recurrent symptoms. As a result, patients often continue the low FODMAP elimination diet for additional months because they have difficulties knowing how to add back FODMAPs into their diet. There are no studies to date to help guide patients with FODMAP reintroduction.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 100% Fructose | Experimental | Other: Dietary InterventionThe fructose group will help to determine whether an absolute amount of fructose will lead to IBS symptoms. |
| 100% Glucose | Placebo comparator | Other: Dietary InterventionThe 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. |
| Fructose and Glucose | Active comparator | Other: Dietary InterventionThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary InterventionFood 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. | Other | 100% Fructose, 100% Glucose, Fructose and Glucose |
Primary outcome
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?"
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.
8 secondary outcomes
Change in IBS-symptom severity scale
Time frame: 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)
Change in Personal Health Questionnaire (PHQ-15)
Time frame: 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)
Change in overall severity of gastrointestinal symptoms
Time frame: 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)
Change in intestinal microbiota
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lin Chang, MD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary Intervention in people with Irritable Bowel Syndrome With Diarrhea and Irritable Bowel Syndrome With Mixed Bowel Habits, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adequate relief of IBS symptoms in past 7 days (time frame: Baseline, 4 weeks (post-elimination diet)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2023.