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.

Age range18 Years

SexALL

See this in plain English?

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

✓. 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

✕. 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
✕. Concurrent organic GI pathology other than benign polyps, diverticulosis, hemorrhoids, lipomas and melanosis coli
✕. Previous abdominal surgery with the exception of hernia repair, appendectomy, caesarian section, tubal ligation, hysterectomy, hemorrhoidectomy
✕. Patients who received antibiotics in the previous 2 weeks
✕. women of childbearing potential not willing to use an effective contraception method

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)

NCT IDNCT03775499

SponsorSociété des Produits Nestlé (SPN)

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-10-04

Who can participate

Age range18 Years

SexALL

See this in plain English?

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

✓. 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

✕. 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
✕. Concurrent organic GI pathology other than benign polyps, diverticulosis, hemorrhoids, lipomas and melanosis coli
✕. Previous abdominal surgery with the exception of hernia repair, appendectomy, caesarian section, tubal ligation, hysterectomy, hemorrhoidectomy
✕. Patients who received antibiotics in the previous 2 weeks
✕. women of childbearing potential not willing to use an effective contraception method