Bifidobacterium Infantis NLS Super Strain for Celiac Disease Patients on a Gluten-free Diet With Persistent Gastrointestinal Symptoms

Phase

Condition

Celiac Disease

Treatment

N/A

Clinical Study ID

NCT03271138

GlobalIP

001

Ages > 18
All Genders

Study Summary

The primary purpose of this randomized, double-blinded, placebo-controlled, crossover clinical trial is to evaluate the efficacy of dietary supplementation with Bifidobacterium infantis NLS super strain among celiac disease patients on a gluten-free who have persistent gastrointestinal symptoms.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Men or women at least 18 years of age
Precise diagnosis of celiac disease: serology (a-tTG IgA and/or DGP IgG and/or EmA)and histology (Marsh IIIa or greater) concordantly positive, confirmed atinvestigator's institution
Consuming a gluten-free diet for at least 2 years
Persistent gastrointestinal symptoms: global GSRS questionnaires ≥2 or ≥ 3 points forany of the 5 sub-dimensions
Signature of informed consent

Exclusion

Exclusion Criteria:

Patients not interested or unable to comply with questionnaires and collection ofsamples of blood, feces, and urine
Complicated celiac disease (refractory, ulcerative jejunoileitis, lymphoma)
Concomitant pathologies that are uncompensated or untreated (Type I or II diabetesmellitus, hyperthyroidism, hypothyroidism, diarrhea due to bile salts, pancreaticinsufficiency, bacterial overgrowth)
Consumption within the 2 weeks prior to study enrollment of medication that interfereswith bowel functioning (antibiotics, NSAIDs, laxatives, metformin, opiates,anticholinergics [atropine, antidepressants, neuroleptics, antipsychotics,antiparkinsonians], anticonvulsants, antihistamines, antihypertensives [calciumantagonists, clonidine, diuretics, metal ions (aluminum), antacids, sucralfate, bariumsulfate, bismuth, calcium, iron, heavy metals (arsenic, lead, mercury)], resins (cholestyramine), or any other medication deemed relevant by the investigator).
Women that are pregnant or may become pregnant during the study

Study Design

July 21, 2017

December 07, 2017

Study Description

Most patients with celiac disease demonstrate substantial clinical improvement during the first few weeks after the onset of the consumption of a gluten-free diet. However, between 30-50% of patients with celiac disease have persistent gastrointestinal symptoms despite consuming a gluten-free diet and presenting negative antibodies. It has recently been reported that celiac disease patients treated with a gluten-free diet that still have persistent symptoms possess different intestinal microbiota patterns than patients without persistent symptoms. Furthermore, a pilot study showed that dietary supplementation with probiotics (Bifidobacterium infantis NLS super strain - Natren LIFESTART®) in untreated celiac disease patients was associated with a significant improvement in symptoms as compared to placebo. Collectively, these findings contribute to the hypothesis that celiac disease patients on a gluten-free diet in whom gastrointestinal symptoms persist may benefit from the supplementation of Bifidobacterium infantis NLS super strain.

Participants in this double-blinded crossover trial will be randomized to receive either placebo or Bifidobacterium infantis NLS super strain for 3 weeks, followed by a 2 week washout period, and then followed by 3 weeks of the other of either placebo or probiotic supplementation.

Connect with a study center

Small Bowel Section, Department of Medicine, Dr. C. Bonorino Udaondo Gastroenterology Hospital
Buenos Aires,
Argentina
Site Not Available

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