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

Primary Purpose

Irritable Bowel Syndrome Characterized by Constipation

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Low FODMAP diet/PEG 3350
sham diet/PEG 3350
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome Characterized by Constipation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of MichiganRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Low FODMAP diet plus PEG 3350

Sham diet plus PEG 3350

Arm Description

Subjects will follow a low FODMAP diet and will take PEG 3350 (Miralax).

Subjects will follow a sham diet and will take PEG 3350 (Miralax).

Outcomes

Primary Outcome Measures

Improvement of abdominal pain as measured by 11-point numerical rating scale
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.

Secondary Outcome Measures

Bloating
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
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
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
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.
during weeks 3 & 4
stool consistency
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
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
assess change in IBS-QOL from baseline and the last week of treatment week 4
HADS score
assess change in HADS score from baseline and the last week of treatment of week 4
WPAI questionnaire
assess change in WPAI questionnaire from baseline and the last week of treatment of week 4
Sleep Assessment questionnaire
assess change in Sleep Assessment questionnaire from baseline and the last week of treatment of week 4

Full Information

First Posted
September 25, 2018
Last Updated
January 18, 2023
Sponsor
University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT03687814
Brief Title
Low FODMAP Plus PEG 3350 for the Treatment of Patients With Irritable Bowel Syndrome-Constipation
Official Title
Low FODMAP Plus PEG 3350 for the Treatment of Patients With Irritable Bowel Syndrome-Constipation
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 8, 2018 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: 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. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome Characterized by Constipation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
78 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low FODMAP diet plus PEG 3350
Arm Type
Experimental
Arm Description
Subjects will follow a low FODMAP diet and will take PEG 3350 (Miralax).
Arm Title
Sham diet plus PEG 3350
Arm Type
Sham Comparator
Arm Description
Subjects will follow a sham diet and will take PEG 3350 (Miralax).
Intervention Type
Other
Intervention Name(s)
Low FODMAP diet/PEG 3350
Other Intervention Name(s)
low FODMAP diet
Intervention Description
Subjects will follow a low FODMAP diet and will take PEG 3350 (Miralax) at 17.7 g (single dose) daily for 4 weeks.
Intervention Type
Other
Intervention Name(s)
sham diet/PEG 3350
Other Intervention Name(s)
sham diet
Intervention Description
Subjects will follow a sham diet and will take PEG 3350 (Miralax) at 17.7 g (single dose) daily for 4 weeks.
Primary Outcome Measure Information:
Title
Improvement of abdominal pain as measured by 11-point numerical rating scale
Description
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.
Time Frame
during weeks 3 and 4
Secondary Outcome Measure Information:
Title
Bloating
Description
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.
Time Frame
each treatment week (4 weeks)
Title
abdominal discomfort
Description
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.
Time Frame
during weeks 3 and 4
Title
Mean number of SBMs per day
Description
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.
Time Frame
week 4
Title
Mean weekly number of spontaneous complete bowel movements
Description
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)
Time Frame
last treatment week
Title
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.
Description
during weeks 3 & 4
Time Frame
during weeks 3 & 4
Title
stool consistency
Description
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
Time Frame
Over the 4 weeks of treatment
Title
Straining
Description
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
Time Frame
4 weeks
Title
IBS-QOL
Description
assess change in IBS-QOL from baseline and the last week of treatment week 4
Time Frame
baseline and week 4
Title
HADS score
Description
assess change in HADS score from baseline and the last week of treatment of week 4
Time Frame
baseline and week 4
Title
WPAI questionnaire
Description
assess change in WPAI questionnaire from baseline and the last week of treatment of week 4
Time Frame
baseline and week 4
Title
Sleep Assessment questionnaire
Description
assess change in Sleep Assessment questionnaire from baseline and the last week of treatment of week 4
Time Frame
baseline and week 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: related to defecation associated with a change in the frequency of stool (reduction of stools) 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stacy Menees, MD, MS
Phone
734-232-3739
Email
sbartnik@med.umich.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Amy Liu, BS
Phone
734-647-4794
Email
liuyalie@med.umich.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stacy B Menees, MD, MS
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stacy Menees, MD

12. IPD Sharing Statement

Learn more about this trial

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

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