Effects of a Nutritional Solution to Improve Intestinal Permeability in Celiac Patients

Celiac Disease Clinical Trial

— Protalsafe  

Official title:

Randomized, Double-blind, Controlled and Parallel Study of the Effect of a New Nutritional Solution to Improve Intestinal Permeability in Celiac Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03483805
• Other study ID #: 2016-A00330-51
• Status: Completed
• Phase: N/A
• First received: March 19, 2018
• Last updated: April 19, 2018
• Start date: December 21, 2016
• Est. completion date: January 12, 2018

Study information

• Verified date: April 2018
• Source: Société Guaranteed Gluten Free (GGF)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Celiac disease (or gluten intolerance) is recognized as one of the most common chronic diseases: prevalence of 1 in 100 to 1/300 people in Europe and the United States. To date, the treatment consists of a total elimination of any source of gluten from the diet. This eviction generates many daily constraints that would explain that more than 50% of patients do not follow this diet correctly. Hidden sources of gluten in a number of foods also carry the burden of this difficulty in effective exclusion. The objective of the ProtAlSafe study is to develop an innovative nutritional approach in the form of a dietary supplement to improve quality of life of patients. The product is not intended to replace a strict gluten-free diet but to propose a nutritional approach in the form of a dietary supplement to improve quality of life of patients. The expected benefits for people consuming the test product are an overall improvement in quality of life and an improvement in biological markers (intestinal permeability, chronic inflammation, etc.) associated with celiac disease.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: January 12, 2018
• Est. primary completion date: January 12, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• celiac disease diagnosis at least 1 year ago

• diagnosis proven through biopsy report or general practioner letter or health insurance cover

• not following a strict gluten free diet (Pavie score 1-3)

• covered by health insurance

• not in exclusion period from another study

Exclusion Criteria:

• pregnant, breastfeeding women or planing pregnancy

• gluten intolerance of non celiac origin or any other dietary intolerance of allergy

• digestive pathology other than celiac disease

• chronic transit problems (diarrhoea or constipation)

• uncontrolled pathology

• diabetes

• medical treatment impacting outcome markers (corticosteroids, NSAIDS, immune suppressor drugs, pancreatic enzymes, amphetamines)

• recent or regular intake of prebiotics, probiotics, food supplements including B vitamins, iron or calcium.

• antibiotics in the past month

• excessive alcohol intake

• drug user

• planing to change tobacco use

• any other reason why the investigator feels the subject may not be compliant

• adults under judicial protection

Related Conditions & MeSH terms

• Celiac Disease

Intervention

Dietary Supplement:
• Protalsafe
mix of prebiotic, probiotic and plant extract in powder form, to be diluted in water
• Placebo
maize maltodextrin in powder form, to be diluted in water

Locations

Country	Name	City	State
France	Institut Pasteur de Lille	Lille

Sponsors (4)

Lead Sponsor	Collaborator
Société Guaranteed Gluten Free (GGF)	Association Française des Intolérants au Gluten (AFDIAG), Institut Pasteur de Lille, Institut Polytechnique UniLaSalle

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lactulose/mannitol recovery in 5-hour urine sample	ratio of the two sugars following ingestion	after 12 weeks of treatment
Primary	serum zonulin	circulating concentration	after 12 weeks of treatment
Secondary	microbiota profile	taxonomic sequencing	baseline and after 12 weeks of treatment
Secondary	digestive health	gastrointestinal symptoms rating scale (GSRS), 13 questions with answers rating from 0 to 3	baseline and after 12 weeks of treatment
Secondary	digestive comfort	visual analogic scale on digestive symptoms, 5 questions with 10cm scale rating from no symptoms (left) to worsening	baseline and after 12 weeks of treatment
Secondary	quality of life- digestive health	celiac disease quality of life questionnaire (F-CDQ), subset of digestive questions	baseline and after 12 weeks of treatment
Secondary	quality of life	celiac disease quality of life questionnaire (F-CDQ)	baseline and after 12 weeks of treatment
Secondary	circulating inflammation markers	concentration of cytokines interleukin-6, tumor necrosis factor-alpha and interleukin-10	baseline and after 12 weeks of treatment