CompletedNot Applicable

Probiotic BL NCC 2705 and Gluten Sensitivity

Netherlands38 participantsStarted 2018-10-09

Plain-language summary

The aim of the study is to confirm/prove safety of the probiotic and production of serpin in humans.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Willing and able to sign written informed consent prior to trial entry
. Male or female adults \>18 years of age
. For NCGS: self-reported gluten sensitivity with negative CD serology, on gluten free diet for at least 6 weeks with self-reported significant symptomatic improvement
. For CD: confirmed serologic and histologic diagnosis of CD and on GFD for at least 12 months with self-reported significant symptomatic improvement
. Body Mass Index (BMI) within the range \>18 - \<30 kg/m2
. Willing and able to comply with study procedures and restrictions
. In good health as determined by a medical history and medical examination

Exclusion criteria

. Documented IgE-mediated food allergy
. Subjects following an overly imbalanced or restrictive diet as per nutritional advice
. Concurrent systemic disease and/or laboratory abnormalities considered by investigators to be detrimental for the participants safety or potentially interfering with the study procedures and/or study outcomes

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

incidence, type and severity of adverse event

Timeframe: from Baseline to end of study (up to maximum 43 days)

Gastro-intestinal tolerability: visual analog scale

Timeframe: from Baseline to end of study (up to maximum 43 days)

Trial details

NCT IDNCT03775499

SponsorSociété des Produits Nestlé (SPN)

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-10-04

View on ClinicalTrials.gov More Celiac Disease trials