Rikshospitalet-Radiumhospitalet HF, Oslo University Hospital
Oslo, Postboks PB 4950 Nydalen, 0424, Norway
NCT Number: NCT03678935
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.
Looking for future studies?
Notify Me18 year–75 year
All sexes
Interventional
Not applicable
Oslo, Postboks PB 4950 Nydalen, 0424, Norway
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The intervention group follows the low FODMAP diet for 4 weeks.
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.
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.
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.
Oslo University Hospital
Other
Effect of Fermentable Oligo-, di-, and Monosaccharides and Polyols (FODMAP) Restriction on Persistent GI-symptoms in Coeliac Patients
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03051204
Celiac Disease, Colitis
Los Angeles, California, United States
View Trial DetailsNCT03011593
Celiac Disease, Colitis
View Trial DetailsNCT03143517
Abdominal Pain, Body Weight
Dothan, Alabama, United States
View Trial DetailsNCT01574209
Celiac Disease, Colonic Diseases
Castellana Grotte, Bari, Italy
View Trial Details