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Dietary Triggers of Gastrointestinal Symptoms in IBS Patients

Primary Purpose

Irritable Bowel Syndrome

Status

Unknown status

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Purified gluten

Non-purified gluten (containing ATIs)

Nocebo

About this trial

This is an interventional other trial for Irritable Bowel Syndrome focused on measuring crossover, gluten, amylase trypsin inhibitors, diet, challenge

Eligibility Criteria

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

Inclusion Criteria:

IBS diagnosis based on Rome IV criteria.
Asymptomatic on a gluten-free diet (IBS-SSS score 0-74).
Compliance with the study procedures (according to the investigator's own judgement).
Signing the Study Informed Consent form.

Exclusion Criteria:

Concurrent systemic disease and/or laboratory abnormalities considered by investigators to be risky or that could interfere with data collection.
Concurrent organic gastrointestinal disease (i.e. Celiac disease, Inflammatory Bowel Disease, peptic ulcer disease, etc.) other than benign polyps, diverticulosis, hemorrhoids, lipoma and melanosis coli.
Major abdominal surgery with the exception of hernia repair, appendectomy, Caesarian section, tubal ligation, cholecystectomy, hysterectomy, and hemorrhoidectomy.
History of active cancer in the last 5 years, other than skin basal cells cancer.
Pregnant or breastfeeding women.
Current use of antibiotics or antibiotic treatment within 1 months before the first visit.
Consumption of probiotics within 1 month prior to the first visit.
Use of non-authorized medications (see Unauthorized Medications section).
Patients on a high fibre diet (>35 g/day for males, > 25 g/day for females), consuming high inulin containing foods (>5 g/day), and/or consuming dietary fibre supplements (as assessed by dietary assessment questionnaire) in the 4 weeks prior to the first visit.
Patients currently participating or having participated in a trial within the past month.

Sites / Locations

McMaster University Medical CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Arm Label

Gluten, ATIs, nocebo

Gluten, nocebo, ATIs

ATIs, gluten, nocebo

ATIs, nocebo, gluten

Nocebo, ATIs, gluten

Nocebo, gluten, ATIs

Arm Description

Participants will start on 1 week of muesli bars with purified gluten followed by 14 days washout. They will then take 1 week of muesli bars with non-purified gluten (containing ATIs) followed by 14 days of washout. Finally, they will have 1 week of nocebo muesli bars (with nothing).

Participants will start on 1 week of muesli bars with purified gluten followed by 14 days washout. They will then take 1 week of nocebo muesli bars (with nothing) followed by 14 days of washout. Finally, they will have 1 week of muesli bars with non-purified gluten (containing ATIs).

Participants will start on 1 week of muesli bars with non-purified gluten (containing ATIs) followed by 14 days washout. They will then take 1 week of muesli bars with purified gluten followed by 14 days of washout. Finally, they will have 1 week of nocebo muesli bars (with nothing).

Participants will start on 1 week of muesli bars with non-purified gluten (containing ATIs) followed by 14 days washout. They will then take 1 week of nocebo muesli bars (containing nothing) followed by 14 days of washout. Finally, they will have 1 week of muesli bars with purified gluten.

Participants will start on 1 week of nocebo muesli bars (with nothing) followed by 14 days washout. They will then take 1 week of muesli bars containing non-purified gluten (containing ATIs) followed by 14 days of washout. Finally, they will have 1 week of muesli bars with purified gluten.

Participants will start on 1 week of nocebo muesli bars (with nothing) followed by 14 days washout. They will then take 1 week of muesli bars with purified gluten followed by 14 days of washout. Finally, they will have 1 week of muesli bars with non-purified gluten (containing ATIs).

Outcomes

Primary Outcome Measures

Irritable Bowel Syndrome (IBS) symptoms

Change in IBS symptoms (using Irritable Bowel Syndrome Symptom Severity Score (IBS-SSS) during dietary challenge compared to nocebo. The overall score ranges from 0-500 in total, with each of the 5 questions ranging from 0 to 100. A higher score indicates higher symptom severity and the total score is summed.

Secondary Outcome Measures

General gastrointestinal symptoms

Change in general gastrointestinal symptoms (using The Patient-Reported Outcomes Measurement Information System (PROMIS Scales) for belly pain, diarrhea, constipation, or gas & bloating) during dietary challenge compared to nocebo. Scores are calculated using the Scoring Service by Health Measures and range from 20-80, with medians set at 50 and a standard deviation of 10. Higher scores indicate greater symptom severity. Four PROMIS subscales are being used: Gas & Bloating, Diarrhea, Constipation, and Belly Pain. Each subscale follows the T-scale scoring range of 20-80 and will be measured independently.

Orocecal transit

Change in colonic transit assessed by SHAPE study (radiopaque markers)

Anti-gliadin antibody (AGA) levels

Change in AGA levels after gluten and gluten+ATI challenge will be assessed by ELISA

Gut microbiota profiles

Change in gut microbiota profiles will be assessed using 16S rRNA Illumina sequencing

Genetic predisposition for celiac disease

Patient HLADQ2/8 status will be assessed at baseline

Depression, anxiety and stress

Change in depression, anxiety, and stress sub-scales during dietary challenge will be assessed by Depression Anxiety Stress Scale (DASS-21). The DASS-21 has 21 questions. The three subscales (depression, anxiety, and stress) will be reported independently and range from 0 to 42, with higher scores indicating greater symptom severity.

Somatic symptoms

Change in somatic symptoms like fatigue, sleeping trouble, and pain will be assessed using Patient Health Questionnaire (PHQ-15). Scores range from 0 to 30, with greater scores indicating greater severity.

Stool consistency

Changes in stool consistency will be assessed by Bristol Stool Scale. Types 1 and 2 indicate harder stools, types 3, 4, and 5 are normal, and types 6 and 7 indicate runnier, more liquid stool.

Gluten levels in stool

Presence of gluten in stool samples will be tested for diet compliance using Anti-GIP immunochromatographic strips

Diet assessment

Dietary tracking will be performed using the MealLogger app

IBS symptom duration

Evaluates symptom duration at the end of the diet challenge using the IBS-SSS. The overall score ranges from 0-500 in total, with each of the 5 questions ranging from 0 to 100. A higher score indicates higher symptom severity and the total score is summed.

Systemic immune reactivity

Assessment of pro-inflammatory cytokines levels using peripheral blood mononuclear cell stimulation (PBMC) stimulation in a subset of patients

Full Information

NCT ID

NCT03664531

First Posted

August 22, 2018

Last Updated

September 25, 2020

Sponsor

McMaster University

1. Study Identification

Unique Protocol Identification Number

NCT03664531

Brief Title

Dietary Triggers of Gastrointestinal Symptoms in IBS Patients

Official Title

Crossover Trial of Gluten and Gluten With Amylase-trypsin Inhibitors as Triggers of Gastrointestinal Symptoms in Patients With Irritable Bowel Syndrome

Study Type

Interventional

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Unknown status

Study Start Date

January 1, 2019 (Actual)

Primary Completion Date

August 2021 (Anticipated)

Study Completion Date

February 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

McMaster University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This crossover randomized controlled trial will evaluate the effects of gluten and gluten combined with amylase-trypsin inhibitors (ATIs) on inducing intestinal and extra-intestinal symptoms in irritable bowel syndrome (IBS) patients. All participants will be put on a gluten-free diet and then challenged with muesli bars containing either purified gluten, gluten with ATIs, or nocebo.

Detailed Description

Irritable bowel syndrome (IBS) is a heterogenous, common gastrointestinal disorder characterized by chronic abdominal pain and altered bowel habits. Many IBS patients report symptom relief on a gluten-free diet (GFD), but it is uncertain whether gluten is the true culprit. The gluten-containing grains wheat, rye, and barley all contain amylase-trypsin inhibitors (ATIs), and a GFD is virtually ATI-free. This double-blinded crossover randomized controlled trial aims to determine which IBS patients are affected by pure gluten and which are affected by gluten combined with ATIs. IBS patients who respond to and have been on a GFD for 3+ weeks will be randomized to receive a dietary challenge of muesli bars containing either 1) pure gluten, 2) non-purified gluten (containing ATIs), 3) or nocebo for a week followed by a 14 day washout. This will be repeated until all participants have had each dietary challenge. The study will evaluate the effects and potential mechanisms of purified and non-purified gluten on intestinal and extra-intestinal symptoms in IBS. It is likely that some IBS patients respond to gluten, while others respond to gluten combined with ATIs. Thus, this project may lead to better diagnosis and individualized dietary treatments for IBS.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Irritable Bowel Syndrome

Keywords

crossover, gluten, amylase trypsin inhibitors, diet, challenge

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Model Description

Participants will be required to be on a gluten-free diet for a period of 3 weeks before starting the study. Participants will then be randomized to take muesli bars containing either purified gluten, non-purified gluten with amylase trypsin inhibitors, or nocebo for 1 week followed by 2 weeks of washout, and then repeated for the two remaining dietary challenges so that at the end all participants have been on all dietary challenges. At the beginning and end of each challenge period, participants will visit the clinic to be evaluated for changes in IBS symptoms.

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

The statistician will also be masked from the treatments.

Allocation

Randomized

Enrollment

34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Gluten, ATIs, nocebo

Arm Type

Experimental

Arm Description

Arm Title

Gluten, nocebo, ATIs

Arm Type

Experimental

Arm Description

Arm Title

ATIs, gluten, nocebo

Arm Type

Experimental

Arm Description

Arm Title

ATIs, nocebo, gluten

Arm Type

Experimental

Arm Description

Arm Title

Nocebo, ATIs, gluten

Arm Type

Experimental

Arm Description

Arm Title

Nocebo, gluten, ATIs

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

Purified gluten

Intervention Description

1 low FODMAPs, vegan muesli bar containing purified gluten per day for 1 week, for a total of 10 g purified gluten per day.

Intervention Type

Other

Intervention Name(s)

Non-purified gluten (containing ATIs)

Intervention Description

1 low FODMAPs, vegan muesli bar containing whole wheat flour with non-purified gluten per day for 1 week, for a total of 10 g non-purified gluten per day.

Intervention Type

Other

Intervention Name(s)

Nocebo

Intervention Description

1 gluten-free, ATI-free, low FODMAPs, vegan muesli bar per day for 1 week. This is a nocebo because we expect that participants will feel worse even though there is no potential irritant.

Primary Outcome Measure Information:

Title

Irritable Bowel Syndrome (IBS) symptoms

Description

Time Frame

1 week gluten or gluten+ATIs intervention compared to nocebo

Secondary Outcome Measure Information:

Title

General gastrointestinal symptoms

Description

Time Frame

1 week gluten or gluten+ATIs intervention compared to nocebo

Title

Orocecal transit

Description

Change in colonic transit assessed by SHAPE study (radiopaque markers)

Time Frame

1 week gluten or gluten+ATIs intervention compared to nocebo

Title

Anti-gliadin antibody (AGA) levels

Description

Change in AGA levels after gluten and gluten+ATI challenge will be assessed by ELISA

Time Frame

Serum AGAs will be measured at baseline and after the challenge

Title

Gut microbiota profiles

Description

Change in gut microbiota profiles will be assessed using 16S rRNA Illumina sequencing

Time Frame

1 week gluten or gluten+ATIs intervention compared to nocebo

Title

Genetic predisposition for celiac disease

Description

Patient HLADQ2/8 status will be assessed at baseline

Time Frame

Patient HLA DQ2/8 status will be measured at baseline

Title

Depression, anxiety and stress

Description

Time Frame

1 week gluten or gluten+ATIs intervention compared to nocebo

Title

Somatic symptoms

Description

Time Frame

1 week gluten or gluten+ATIs intervention compared to nocebo

Title

Stool consistency

Description

Changes in stool consistency will be assessed by Bristol Stool Scale. Types 1 and 2 indicate harder stools, types 3, 4, and 5 are normal, and types 6 and 7 indicate runnier, more liquid stool.

Time Frame

1 week gluten or gluten+ATIs intervention compared to nocebo

Title

Gluten levels in stool

Description

Presence of gluten in stool samples will be tested for diet compliance using Anti-GIP immunochromatographic strips

Time Frame

Procedure will be explained at baseline

Title

Diet assessment

Description

Dietary tracking will be performed using the MealLogger app

Time Frame

Patients will be asked to take pictures of all meals during each of the 1 week diet challenges

Title

IBS symptom duration

Description

Time Frame

Completed daily for 7 days after each diet challenge

Title

Systemic immune reactivity

Description

Assessment of pro-inflammatory cytokines levels using peripheral blood mononuclear cell stimulation (PBMC) stimulation in a subset of patients

Time Frame

1 week gluten or gluten+ATIs intervention compared to nocebo

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: IBS diagnosis based on Rome IV criteria. Asymptomatic on a gluten-free diet (IBS-SSS score 0-74). Compliance with the study procedures (according to the investigator's own judgement). Signing the Study Informed Consent form. Exclusion Criteria: Concurrent systemic disease and/or laboratory abnormalities considered by investigators to be risky or that could interfere with data collection. Concurrent organic gastrointestinal disease (i.e. Celiac disease, Inflammatory Bowel Disease, peptic ulcer disease, etc.) other than benign polyps, diverticulosis, hemorrhoids, lipoma and melanosis coli. Major abdominal surgery with the exception of hernia repair, appendectomy, Caesarian section, tubal ligation, cholecystectomy, hysterectomy, and hemorrhoidectomy. History of active cancer in the last 5 years, other than skin basal cells cancer. Pregnant or breastfeeding women. Current use of antibiotics or antibiotic treatment within 1 months before the first visit. Consumption of probiotics within 1 month prior to the first visit. Use of non-authorized medications (see Unauthorized Medications section). Patients on a high fibre diet (>35 g/day for males, > 25 g/day for females), consuming high inulin containing foods (>5 g/day), and/or consuming dietary fibre supplements (as assessed by dietary assessment questionnaire) in the 4 weeks prior to the first visit. Patients currently participating or having participated in a trial within the past month.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Caroline Seiler, BSc

Phone

905-580-0325

seilercl@mcmaster.ca

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Premysl Bercik, MD

Organizational Affiliation

McMaster University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Maria Ines Pinto-Sanchez, MD

Organizational Affiliation

McMaster University

Official's Role

Study Director

Facility Information:

Facility Name

McMaster University Medical Centre

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8N 3Z5

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Caroline Seiler, BSc

Phone

905-580-0325

seilercl@mcmaster.ca

12. IPD Sharing Statement

Plan to Share IPD

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Dietary Triggers of Gastrointestinal Symptoms in IBS Patients

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