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

NCT03678935 | Completed

• 1 other identifier: 2018/1055
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Diet Modification; Gluten Sensitivity; Irritable Bowel Syndrome; Celiac Disease

Keywords

Celiac disease; Irritable bowel syndrome

Outcome Measures

Primary Outcomes (1)

• Change in gastrointestinal symptoms

  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.

  4 weeks

Secondary Outcomes (2)

• Changes in biomarkers like faecal microbiota

  4 weeks

• Quality of Life in patients with coeliac disease: Short form- 36 (SF-36)

  4 weeks

Study Arms (2)

Low FODMAP diet (LFD)

ACTIVE COMPARATOR

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

Control

NO INTERVENTION

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.

Interventions

Low FODMAP diet OTHER

The intervention group follows the low FODMAP diet for 4 weeks.

Low FODMAP diet (LFD)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (1)

Rikshospitalet-Radiumhospitalet HF, Oslo University Hospital

Oslo, Postboks PB 4950 Nydalen, 0424, Norway

Location

Related Publications (5)

• van Megen F, Skodje GI, Lergenmuller S, Zuhlke S, Aabakken L, Veierod MB, Henriksen C, Lundin KEA. A Low FODMAP Diet Reduces Symptoms in Treated Celiac Patients With Ongoing Symptoms-A Randomized Controlled Trial. Clin Gastroenterol Hepatol. 2022 Oct;20(10):2258-2266.e3. doi: 10.1016/j.cgh.2022.01.011. Epub 2022 Jan 17.

  PMID: 35051648 RESULT

• van Megen F, Fossli M, Skodje GI, Carlsen MH, Andersen LF, Veierod MB, Lundin KEA, Henriksen C. Nutritional assessment of women with celiac disease compared to the general population. Clin Nutr ESPEN. 2023 Apr;54:251-257. doi: 10.1016/j.clnesp.2023.01.031. Epub 2023 Feb 2.

  PMID: 36963870 RESULT

• Skodje GI, van Megen F, Stendahl M, Henriksen C, Lundin KEA, Veierod MB. Detection of gluten immunogenic peptides and the Celiac Disease Adherence Test to monitor gluten-free diet: a pilot study. Eur J Clin Nutr. 2022 Jun;76(6):902-903. doi: 10.1038/s41430-021-01054-6. Epub 2022 Jan 10.

  PMID: 35001079 RESULT

• van Megen F, Skodje GI, Stendahl M, Veierod MB, Lundin KEA, Henriksen C. High disease burden in treated celiac patients - a web-based survey. Scand J Gastroenterol. 2021 Aug;56(8):882-888. doi: 10.1080/00365521.2021.1930146. Epub 2021 May 30.

  PMID: 34057009 RESULT

• Herfindal AM, van Megen F, Gilde MKO, Valeur J, Rudi K, Skodje GI, Lundin KEA, Henriksen C, Bohn SK. Effects of a low FODMAP diet on gut microbiota in individuals with treated coeliac disease having persistent gastrointestinal symptoms - a randomised controlled trial. Br J Nutr. 2023 Dec 28;130(12):2061-2075. doi: 10.1017/S0007114523001253. Epub 2023 Jun 5.

  PMID: 37272479 RESULT

MeSH Terms

Conditions

Celiac Disease; Irritable Bowel Syndrome

Interventions

FODMAP Diet

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Colonic Diseases, Functional; Colonic Diseases

Intervention Hierarchy (Ancestors)

Elimination Diets; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Knut Lundin, Professor

  Oslo University hospital and University of Oslo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor medicine

Model Details: The intervention group receives advice on following the low-FODMAP diet, and the control group follows their regular gluten free diet.

Study Record Dates

• First Submitted: September 17, 2018
• First Posted: September 20, 2018
• Study Start: October 1, 2018
• Primary Completion: July 28, 2025
• Study Completion: July 28, 2025
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)