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Effect of FODMAP Restriction on Persistent GI-symptoms in Coeliac Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03678935
Recruitment Status : Active, not recruiting
First Posted : September 20, 2018
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Knut E. A. Lundin, Oslo University Hospital

Brief Summary:

The first aim of the study is to investigate the prevalence of persistent gastrointestinal symptoms and compliance with gluten-free diet and the intake of FODMAP in adult celiac patients.

A web-based survey wil be performed and thereafter a randomized controlled trial to test the effect of a FODMAP reduction in patients with celiac disease with irritable bowel-like symptoms.


Condition or disease Intervention/treatment Phase
Celiac Disease Irritable Bowel Syndrome Diet Modification Gluten Sensitivity Other: Low FODMAP diet Not Applicable

Detailed Description:

Effect of FODMAP reduction in patients with celiac disease. Celiac disease is an immune-mediated disease that causes damage to the intestines. The condition affects 1-2% of the population, and the incidence is increasing. Treatment with gluten-free diet usually produces good results, yet there are many patients who have persistent gastrointestinal symptoms. Studies indicate that this applies to as many as 20%, but the situation in Norway in unknown. Nor is it known why somebody has persistent gastro- intestinal complaints. It may be due to difficulty following the diet or what is called irritable bowel syndrome (IBS), which is a fairly common condition in the population.

It has been shown that people with IBS can benefit from a diet with reduced FODMAP content. The term FODMAP is an acronym for: Fermentable Oligo, Di-, Monosaccharides and Polyols. It is a type of carbohydrate that is not absorbed in the large intestine, but continues to the colon where they are fermented by the bacteria. Example of foods with a high content of FODMAP is wheat, onion, garlic, parsley, apples, pears, mango, beans, honey and milk. It is not known whether celiac patients with persistent symptoms will have the beneficial effect of low FODMAP diet.

In this study, investigators want to study the prevalence of persistent gastrointestinal symptoms and compliance with gluten-free diet and the intake of FODMAP in adult celiac patients. Members of the Norwegian coeliac organization will be invited to participate in the study. A web-based questionnaire is used to make it easy for members to respond.

Participants who report persistent gastrointestinal intestinal symptoms will then be invited to a randomized and controlled study. They will be divided into two groups where one group will be advised to reduce the intake of FODMAP and the other group will be advised to follow a strict gluten-free diet. Participants will record stomach and intestinal complaints before and after four weeks with study sites. Investigators will find out whether there is a difference between gastric and intestinal complaints between the two groups. Blood- and feces samples will also be collected.

The results will provide new knowledge about how to adapt dietary advice to celiac patients with persistent gastrointestinal complaints, and hopefully help them to a better quality of life.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The intervention group receives advice on following the low-FODMAP diet, and the control group follows their regular gluten free diet.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Fermentable Oligo-, di-, and Monosaccharides and Polyols (FODMAP) Restriction on Persistent GI-symptoms in Coeliac Patients
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : June 1, 2019
Estimated Study Completion Date : October 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Celiac Disease

Arm Intervention/treatment
Active Comparator: Low FODMAP diet (LFD)
The LFD wil receive advice on how to follow a low FODMAP diet. They wil follow this diet for 4 weeks. Thereafter they receive advice on how to reintroduce high FODMAPs again.
Other: Low FODMAP diet
The intervention group follows the low FODMAP diet for 4 weeks.

No Intervention: Control
Control group. Participants follow their regular gluten-free diet (GFD), with no changes to their diet. They wil receive the same dietary advice as the LFD-group after the 4-week study.



Primary Outcome Measures :
  1. Change in gastrointestinal symptoms [ Time Frame: 4 weeks ]
    Measured by score in gastrointestinal symptom rating scale for irritable bowel syndrome (GSRS-IBS). The scoring is based on a 7-grade Likert scale in which 1 point indicates no symptoms and 7 points the most severe gastrointestinal symptoms. The total score in the gastrointestinal symptom rating scale for irritable bowel syndrome is calculated as a mean value of all 13 items. The maximum score is 91 and the minimum score is 13. A higher score means more severe symptoms. A score higher than 1 standard deviation (SD, 0.66 points) compared to the control mean are considered to have increased gastrointestinal symptoms.


Secondary Outcome Measures :
  1. Changes in biomarkers like faecal microbiota [ Time Frame: 4 weeks ]
    Altered faecal microbiota diversity, measured as a change in diversity and/or abundance or strains from baseline and after 4 weeks on a low FODMAP diet.

  2. Quality of Life in patients with coeliac disease: Short form- 36 (SF-36) [ Time Frame: 4 weeks ]
    Changes in short form-36 (SF-36) as a measure of quality of life. SF-36 covers four physical health perceptions (physical functioning, role limitations because of physical health problems, bodily pain, and general health) and four mental health concepts (vitality, social functioning, role limitations because of personal or emotional problems, and mental health perceptions). Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The range of score is 0 to 100, where a higher score means better quality of life and the lower the score the more disability. A total score for mental health and physical health is calculated as an average of the subscales, with a range from 0 to 100. Here also the higher the score the better quality of life. The standardized combined scores in several populations have a mean of 50 and standard deviation 10. The scoring wil be performed as in the SF-36 scoring manual.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Coeliac disease
  • Adherent to GFD for at least 12 months
  • Strictly adherent to GFD
  • Normal coeliac disease (CD) serology and duodenal biopsy (Marsh 0-1)
  • Persistent GI-symptoms defined by GSRS-IBS score of 30 or more
  • Living less than 2 hour from study centre

Exclusion Criteria:

  • Pregnancy or lactating women
  • Use of immunomodulating drugs in the last 3 months
  • Use of anti-inflammatory drugs in the last 3 months
  • Use of antacid drugs in the last 2 months
  • Ongoing infection (mild infection such as upper airway infection is ok)
  • Other chronical bowel disorder (except for IBS)
  • Previous tried the LFD with guidance of a dietician

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03678935


Locations
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Norway
Rikshospitalet-Radiumhospitalet HF, Oslo University Hospital
Oslo, Postboks PB 4950 Nydalen, Norway, 0424
Sponsors and Collaborators
Oslo University Hospital
Investigators
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Principal Investigator: Knut Lundin, Professor Oslo University hospital and University of Oslo
  Study Documents (Full-Text)

Documents provided by Knut E. A. Lundin, Oslo University Hospital:
Study Protocol  [PDF] June 1, 2018


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Responsible Party: Knut E. A. Lundin, Professor medicine, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT03678935     History of Changes
Other Study ID Numbers: 2018/1055
First Posted: September 20, 2018    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Knut E. A. Lundin, Oslo University Hospital:
Celiac disease
Irritable bowel syndrome

Additional relevant MeSH terms:
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Irritable Bowel Syndrome
Celiac Disease
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Malabsorption Syndromes
Metabolic Diseases