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Low FODMAP Plus PEG 3350 for the Treatment of Patients With Irritable Bowel Syndrome-Constipation

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ClinicalTrials.gov Identifier: NCT03687814
Recruitment Status : Recruiting
First Posted : September 27, 2018
Last Update Posted : November 22, 2018
Sponsor:
Information provided by (Responsible Party):
Stacy Menees, University of Michigan

Tracking Information
First Submitted Date  ICMJE September 25, 2018
First Posted Date  ICMJE September 27, 2018
Last Update Posted Date November 22, 2018
Actual Study Start Date  ICMJE November 8, 2018
Estimated Primary Completion Date November 3, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 26, 2018)
Improvement of abdominal pain as measured by 11-point numerical rating scale [ Time Frame: during weeks 3 and 4 ]
Compare the proportion of patients with IBS-C on a diet of low FODMAP diet plus PEG 3350 vs. sham diet plus PEG 3350 reporting an improvement of abdominal pain. It is defined 30% reduction in abdominal pain during weeks 3 & 4 of each diet compared with baseline using an 11-point numerical rating scale (NRS) (0-no pain, 11-intolerable pain). Appropriate between-group statistical comparisons will be conducted.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03687814 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 26, 2018)
  • Bloating [ Time Frame: each treatment week (4 weeks) ]
    The change in mean score from baseline on the daily 11-point NRS averaged over each treatment week for bloating severity will be compared between the 2 groups.
  • abdominal discomfort [ Time Frame: during weeks 3 and 4 ]
    30% reduction in abdominal discomfort during weeks 3 & 4 of each diet compared with baseline using an 11-point NRS. Appropriate between-group statistical comparisons will be conducted.
  • Mean number of SBMs per day [ Time Frame: week 4 ]
    These will be measured in the last treatment week (the 7-day period before visit 4): The proportion of responders between the 2 groups will be compared. An SBM was defined as a bowel movement that occurred without the use of rescue medication or ≥24 h after the use of rescue medication.
  • Mean weekly number of spontaneous complete bowel movements [ Time Frame: last treatment week ]
    These will be tallied in the last treatment week (the 7-day period before visit 4):(SCBMs; derived from the number of SBMs without a feeling of incomplete evacuation)
  • Composite endpoint: Full responder was defined as a patient with >3 SBM per week, an increase of ≥1 SBM per week and >30% pain reduction. [ Time Frame: during weeks 3 & 4 ]
    during weeks 3 & 4
  • stool consistency [ Time Frame: Over the 4 weeks of treatment ]
    a responder will be defined as one who reports an increase 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 an increase in BSFS value of ≥1
  • Straining [ Time Frame: 4 weeks ]
    The change from baseline in daily numerical rating scale scored as 0 (none), 1 (slight), 2 (mild), 3 (moderate) and 4 (severe) scores averaged over each treatment week for straining will be compared between the 2 groups
  • IBS-QOL [ Time Frame: baseline and week 4 ]
    assess change in IBS-QOL from baseline and the last week of treatment week 4
  • HADS score [ Time Frame: baseline and week 4 ]
    assess change in HADS score from baseline and the last week of treatment of week 4
  • WPAI questionnaire [ Time Frame: baseline and week 4 ]
    assess change in WPAI questionnaire from baseline and the last week of treatment of week 4
  • Sleep Assessment questionnaire [ Time Frame: baseline and week 4 ]
    assess change in Sleep Assessment questionnaire from baseline and the last week of treatment of week 4
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Low FODMAP Plus PEG 3350 for the Treatment of Patients With Irritable Bowel Syndrome-Constipation
Official Title  ICMJE Low FODMAP Plus PEG 3350 for the Treatment of Patients With Irritable Bowel Syndrome-Constipation
Brief Summary Consecutive patients with Irritable Bowel Syndrome with Constipation (IBS-C) will be recruited from the outpatient clinics of the University of Michigan Health System. Eligible patients will be asked to participate in a study that will test the efficacy the PEG 3350 + a diet low in fermentable oligo, di, monosaccharides, and polyols (FODMAP) vs. PEG 3350 plus sham diet. Blinding dietary advice trials is challenging and therefore the sham diet was based on the criteria set forth by Staudacher et al. which emphasizes that the diet must give the impression that is the true intervention diet with similar restrictions, modifications, and time intensity without impacting the intake of essential nutrients, fiber, and FODMAPs. An example of the sham diet's carbohydrates includes: apples, bananas, and pears, and wheat. Oranges, raspberries, strawberries and rice would not be allowed. Additionally, the physicians analyzing the data will be blinded as to which group the patients were randomized.
Detailed Description

A. Specific Aims: While a diet low in fermentable oligo, di, monosaccharides and polyols (FODMAPs) has gained popularity as a treatment for patients with Irritable Bowel Syndrome and diarrhea (IBS-D), the impact of this diet on patients with IBS and constipation (IBS-C) is unknown. We propose a randomized, controlled trial in IBS-C patients to compare the efficacy of PEG 3350 and the low FODMAP diet to PEG 3350 and a sham diet. We hypothesize that:

  1. The PEG 3350 and low FODMAP diet group will achieve greater improvements in abdominal symptoms including pain, discomfort, and bloating than the group receiving PEG 3350 and the sham diet.
  2. The PEG 3350 and low FODMAP diet group will achieve greater improvements in IBS related quality of life and anxiety than the group receiving PEG 3350 and the sham diet.
  3. Both strategies will improve constipation related complaints including stool frequency, stool consistency and straining to a similar degree.

We plan to test our central hypothesis and, thereby, accomplish the objective of this application by pursuing the following 2 specific aims:

Aim 1: Compare the proportion of patients with IBS-C on a diet of low FODMAP diet plus PEG 3350 vs. sham diet plus PEG 3350 reporting an improvement of abdominal pain. Our working hypothesis is that a higher proportion of patients randomized to the low FODMAP diet plus PEG 3350 will experience a reduction in the abdominal pain when compared to PEG 3350 plus sham diet alone.

Aim 2: Compare the efficacy of the low FODMAP diet plus PEG 3350 vs. sham diet plus PEG 3350 on pre-specified key clinical and disease specific quality of life endpoints in patients with IBS-C. Through our randomized controlled trial, we will assess the impact of the dietary interventions on stool consistency, stool frequency, and bloating and quality of life endpoints.

A positive result to this study would have significant impact on the treatment of patients with IBS by expanding the indications for the low FODMAP diet to all affected patients, regardless of bowel subtype. This would be particularly relevant to IBS-C patients for whom we currently have few evidence-based diet recommendations outside of increasing fiber intake.

Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Irritable Bowel Syndrome Characterized by Constipation
Intervention  ICMJE
  • Other: Low FODMAP diet/PEG 3350
    Subjects will follow a low FODMAP diet and will take PEG 3350 (Miralax) at 17.7 g (single dose) daily for 4 weeks.
    Other Name: low FODMAP diet
  • Other: sham diet/PEG 3350
    Subjects will follow a sham diet and will take PEG 3350 (Miralax) at 17.7 g (single dose) daily for 4 weeks.
    Other Name: sham diet
Study Arms  ICMJE
  • Experimental: Low FODMAP diet plus PEG 3350
    Subjects will follow a low FODMAP diet and will take PEG 3350 (Miralax).
    Intervention: Other: Low FODMAP diet/PEG 3350
  • Sham Comparator: Sham diet plus PEG 3350
    Subjects will follow a sham diet and will take PEG 3350 (Miralax).
    Intervention: Other: sham diet/PEG 3350
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 26, 2018)
78
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 3, 2020
Estimated Primary Completion Date November 3, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

1. Subjects aged 18 and older meeting the Rome IV criteria for IBS-C*:

• Recurrent abdominal pain, on average, at least 1 day/week in the last 3 months, associated with two or more of the following:

  1. related to defecation
  2. associated with a change in the frequency of stool (reduction of stools)
  3. associated with a change in the form of stool (hard or lumpy stools) AND >25% hard stools and <25% loose stools * Criteria fulfilled for the last 3 months

Exclusion Criteria:

  • any other IBS subtype other than IBS-C
  • >3 spontaneous bowel movements during the last 7 days of run-in
  • Have cognitive dysfunction or unable to understand or provide written informed consent
  • Pregnancy (evaluated by self-report)
  • Comorbid medical problems that may affect gastrointestinal transit or motility:
  • Inflammatory bowel disease
  • Extra-intestinal disease known to affect the gastrointestinal system (i.e., scleroderma, unstable thyroid disease, etc.)
  • Severe renal or hepatic disease
  • Previous abdominal surgery other than appendectomy, cholecystectomy, and gynecologic/urologic surgery if performed more than six months prior to enrollment
  • Previous treatment with the low FODMAP diet under a dietician guidance
  • Concurrent medications not permitted including probiotics, antibiotics, prescription or over-the-counter medication for IBS, and narcotics
  • New antidepressant use (less than 3 months on stable dose)
  • Active participation in another form of dietary therapy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Stacy Menees, MD 734-232-3739 sbartnik@med.umich.edu
Contact: Elaine Brady, MBA 734-647-4794 embrady@med.umich.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03687814
Other Study ID Numbers  ICMJE HUM00139784
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Stacy Menees, University of Michigan
Study Sponsor  ICMJE University of Michigan
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Michigan
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP