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Irritable Bowel SyndromeNCT01624610

Comparing the Effectiveness of 2 Diets for Patients With Irritable Bowel Syndrome

A study testing Dietary intervention in people with Irritable Bowel Syndrome, run by University of Michigan at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of the study is to find out if the diets often recommended for patients with Irritable Bowel Syndrome with diarrhea (IBS-D) provide adequate relief. The study will compare two diets that are used to treat IBS-D symptoms to see which one is more effective. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Irritable Bowel Syndrome
What is being tested?
Dietary intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
2 sitesUnited States
Study dates
Jul 2012to Nov 2015
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

  • Meet Rome III criteria for IBS as assessed by a gastroenterologist:
  • Fulfill the Rome III stool consistency criteria for IBS -D
  • Willingness to maintain a stable dosage of IBS medications during the pretreatment baseline period, including tricyclic antidepressants; "rescue" medications permitted (ie Loperamide 2mg up to 4 times per day prn diarrhea)
  • Ability to provide written informed consent for study participation
  • Capable of independently completing all requirements of the study including returning for required visits
  • Documentation of normal colonoscopy with colon biopsies within five years
  • Documentation of normal TSH, CBC, electrolyte panel
  • Negative evaluation for celiac disease either with normal TTG, EMA, and/or duodenal biopsy.

Who cannot join

  • Unable to understand or provide written informed consent
  • Pregnancy
  • IBS with constipation or mixed subtype
  • Comorbid medical problems that may affect gastrointestinal transit or motility:
  • Inflammatory bowel disease
  • Extraintestinal disease known to affect the gastrointestinal system (ie, scleroderma, unstable thyroid disease, diabetes mellitus, etc.)
Show all 12Show fewer
  • Severe renal or hepatic disease
  • Previous abdominal surgery other than appendectomy, cholecystectomy, and gynecologic/urologic surgery
  • Previous treatment with some diets for IBS
  • Concurrent medications not permitted including probiotics, antibiotics, and narcotics
  • Active participation in another form of dietary therapy
  • Patients who have undergone surgery to the GI tract except appendectomy or cholecystectomy if performed more than six months prior to enrollment.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Indiana University

    Indianapolis, Indiana, 46202

Other trials in United States

About this study

Official title: Comparing the Effectiveness of Two Diets to Control the Symptoms of Irritable Bowel Syndrome With Diarrhea (IBS-D): a Randomized, Controlled Trial and Gastrointestinal Microbiome Analysis

The purpose of the study is to find out if the diets often recommended for patients with Irritable Bowel Syndrome with diarrhea (IBS-D) provide adequate relief. The study will compare two diets that are used to treat IBS-D symptoms to see which one is more effective. The study will also measure the effect of these diets on the bowel flora, which are the good bacteria that inhabit the bowels in healthy people.

Read the detailed description

As irritable bowel syndrome (IBS) symptoms are often refractory to conventional therapies, there has been increasing interest in the role of diet in IBS. Certain foods may exacerbate symptoms of IBS. Thus, restricted diets have recently gained attention for the treatment IBS. The mechanism by which symptoms are improved is unclear, but these diets may improve symptoms by exerting changes on the GI microbiome.

Aims:

Primary Objective:

-Compare the proportion of patients with irritable bowel syndrome (IBS-D) reporting adequate relief on Diet 1 vs Diet 2

Secondary Objectives:

  • Assess the effects of these diets in patients with diarrhea-predominant IBS on the gastrointestinal microbiota and blood based biomarkers.
  • Compare the efficacy of Diet 1 vs Diet 2 in patients with diarrhea-predominant IBS on pre-specified clinical and quality of life endpoints.

Methods:

This is a prospective randomized control trial of adults meeting the Rome III criteria for irritable bowel syndrome with diarrhea (IBS-D). After a 2 week screening period and randomization, during which the severity of symptoms will be assessed and eligibility determined, patients will be randomized to Diet 1 vs Diet 2 for a period of 4 weeks.

The primary endpoint will be a comparison of the proportion of patients in each group reporting adequate relief of their IBS symptoms. For the secondary clinical outcomes, a responder definition incorporating abdominal pain and stool consistency as proposed by the FDA will be utilized. Key IBS-D symptoms will be assessed daily and adequate relief of IBS-D symptoms will be assessed weekly during the randomization period. We will also determine if a difference can be detected with high probability in the relative abundance and variety of specific bacterial taxa between the two groups before and after the 4 week dietary intervention. In addition, blood samples will be collected before and after randomization to measure relevant biomarkers of immune activation.

Keywords
Irritable bowel syndrome, Diarrhea, abdominal pain, diet, nutrition
Medical subject headings
Irritable Bowel Syndrome, Diarrhea, Abdominal Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dietary interventionOther

    After a 14 day screening period, subjects will be randomized to 1 of 2 diets to treat their IBS symptoms. They will receive dietary instruction and are expected to remain on this diet for 4 weeks.

Study groups in NCT01624610
Study groupRoleWhat they receive
Diet 1Active comparatorPatients randomized to this arm will receive both written and face-to-face advice about how the components of Diet 1 can be used to control their IBS symptoms.
Receives: Other: Dietary intervention
Diet 2Active comparatorPatients randomized to this arm will receive both written and face-to-face advice about how the components of Diet 2 can be used to control their IBS symptoms.
Receives: Other: Dietary intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of patients with adequate relief.

    Compare the proportion of patients with irritable bowel syndrome (IBS-D) reporting adequate relief on Diet 1 v Diet 2.

    Measured: 4 weeks

Secondary outcomes (8)

  1. Composite endpoint

    Composite endpoint: A responder will report a ≥30% reduction in mean daily abdominal pain score and a decrease in mean daily BSFS value of ≥1 compared to baseline for ≥2 of 4 treatment weeks. The proportion of responders between the 2 groups will be compared.

    Measured: 4 weeks

  2. Abdominal Pain

    An abdominal pain responder will report a ≥30% reduction in mean daily abdominal pain score compared to baseline for ≥2 of 4 treatment weeks. The proportion of responders between the two groups will be compared. Between group differences in the proportion of patients with a ≥30% reduction in mean daily abdominal pain score compared to baseline at the end of each treatment week will also be assessed.

    Measured: 4 weeks

  3. Stool consistency

    For stool consistency, a responder will be defined as one who reports a decrease in mean daily BSFS value of 1 or more compared to baseline for ≥2 of 4 treatment weeks. The proportion of responders between the 2 groups will be compared. Between group differences in the proportion of patients with a decrease in BSFS value of ≥1 compared to baseline at the end of each treatment week will also be assessed.

    Measured: 4 weeks

  4. Stool frequency

    The number of bowel movements will be recorded each day by IVRS. The change from baseline in mean daily stool frequency for each treatment week will be compared for the two groups.

    Measured: 4 weeks

  5. Individual symptoms

    The change from baseline in daily NRS scores averaged over each treatment week for abdominal discomfort, urgency, bloating, and fatigue will compared between the 2 groups.

    Measured: 4 weeks

  6. Quality of life measures

    IBS-Quality of Life scores, Hospital Depression Anxiety Scores, Work Productivity and Activity Impairment questionnaire, and Sleep Assessment questionnaires will be compared between groups before and after the dietary intervention.

    Measured: 4 weeks

  7. Stool Microbiome

    The effect of these 2 diets on the gut microbiome (number and species) in the context of IBS is not known. A change in the microbiota may be a mechanism through which symptom response is mediated.

    We will be measuring the shift in the relative abundance (richness) and variety (diversity) of gut microbial taxa in patients with irritable bowel syndrome (IBS-D) in response to dietary intervention. Stool microbiome would be collected and analyzed using the PhyloChip™ Assay (Second Genome Inc., San Bruno, CA).

    Measured: 4 weeks

  8. Serum Biomarker Panel

    Recent attempts have been made to identify a serological biomarker profile (Prometheus Therapeutics \& Diagnostics, San Diego, CA) which accurately identifies patients with IBS. We intend to perform a biomarker test panel at enrollment in all study subjects to assess whether specific combinations of biomarkers can positively or negatively predict response to either diet.

    Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jun 2012 (estimated)
  2. Study startJul 2012
  3. Primary completionOct 2015
  4. Study completionNov 2015

Resources

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
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01624610
Sponsor's protocol ID
UMGI-DIETIBS
Status last verified
Mar 2016
First submitted
18 Jun 2012
Last updated
31 Mar 2016
Results posted
No
Data monitoring committee
No

Publications

  • Eswaran S, Chey WD, Jackson K, Pillai S, Chey SW, Han-Markey T. A Diet Low in Fermentable Oligo-, Di-, and Monosaccharides and Polyols Improves Quality of Life and Reduces Activity Impairment in Patients With Irritable Bowel Syndrome and Diarrhea. Clin Gastroenterol Hepatol. 2017 Dec;15(12):1890-1899.e3. doi: 10.1016/j.cgh.2017.06.044. Epub 2017 Jun 28.

    PubMed 28668539

Questions about this trial

What is this clinical trial studying?

A study testing Dietary intervention in people with Irritable Bowel Syndrome, run by University of Michigan at 2 sites 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 8 inclusion and 12 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 31 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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. 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?

Proportion of patients with adequate relief. (time frame: 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01624610, which also lists 1 linked publication.

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 31 Mar 2016; AzTrials last refreshed its copy on 6 Nov 2026.

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