NCT03483805

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 21, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 12, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 12, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 19, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 30, 2018

Completed
Last Updated

April 20, 2018

Status Verified

April 1, 2018

Enrollment Period

1.1 years

First QC Date

March 19, 2018

Last Update Submit

April 19, 2018

Conditions

Celiac Disease

Keywords

synbioticnutritionpermeabilitygluten free dietquality of lifedigestive comfort

Outcome Measures

Primary Outcomes (2)

  • Lactulose/mannitol recovery in 5-hour urine sample

    ratio of the two sugars following ingestion

    after 12 weeks of treatment

  • serum zonulin

    circulating concentration

    after 12 weeks of treatment

Secondary Outcomes (6)

  • microbiota profile

    baseline and after 12 weeks of treatment

  • digestive health

    baseline and after 12 weeks of treatment

  • digestive comfort

    baseline and after 12 weeks of treatment

  • quality of life- digestive health

    baseline and after 12 weeks of treatment

  • quality of life

    baseline and after 12 weeks of treatment

  • +1 more secondary outcomes

Study Arms (2)

Treatment

EXPERIMENTAL

Protalsafe product, daily, 12 weeks

Dietary Supplement: Protalsafe

Placebo

PLACEBO COMPARATOR

Placebo product, daily, 12 weeks

Dietary Supplement: Placebo

Interventions

ProtalsafeDIETARY_SUPPLEMENT

mix of prebiotic, probiotic and plant extract in powder form, to be diluted in water

Treatment
PlaceboDIETARY_SUPPLEMENT

maize maltodextrin in powder form, to be diluted in water

Placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Pasteur de Lille

Lille, France

Location

MeSH Terms

Conditions

Celiac Disease

Condition Hierarchy (Ancestors)

Malabsorption SyndromesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2018

First Posted

March 30, 2018

Study Start

December 21, 2016

Primary Completion

January 12, 2018

Study Completion

January 12, 2018

Last Updated

April 20, 2018

Record last verified: 2018-04

Locations

FR(1)