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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-21

Study Completion Date

2017-12-07

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Celiac Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Bifidobacterium Infantis NLS Super Strain

Participants in the probiotic period will take two capsules of Bifidobacterium infantis NLS super strain (Natren LIFE START®2) three times per day for three weeks. Each capsule contains 2 x 10\^9 colony-forming units (CFU) of Bifidobacterium infantis NLS super strain, for a total daily dose of 12 X 10\^9 CFU. The probiotic will be kept refrigerated during transportation and throughout the study period.

Group Type ACTIVE_COMPARATOR

Bifidobacterium infantis NLS super strain (Natren LIFE START®2)

Intervention Type DIETARY_SUPPLEMENT

2 capsules, 3 times per day, for daily total of 12x10\^9 CFU Bifidobacterium infantis NLS super strain

Placebo

Participants in the placebo period will take two capsules of placebo three times per day for three weeks. The placebo capsules contain rice flour, hydroxypropyl and methylcellulose. The placebo will be kept refrigerated during transportation and throughout the study period.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

2 capsules, 3 times per day, containing rice flour, hydroxypropyl and methylcellulose

Interventions

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Bifidobacterium infantis NLS super strain (Natren LIFE START®2)

2 capsules, 3 times per day, for daily total of 12x10\^9 CFU Bifidobacterium infantis NLS super strain

Intervention Type DIETARY_SUPPLEMENT

Placebo

2 capsules, 3 times per day, containing rice flour, hydroxypropyl and methylcellulose

Intervention Type OTHER

Eligibility Criteria

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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 at investigator's institution
* Consuming a gluten-free diet for at least 2 years
* Persistent gastrointestinal symptoms: global GSRS questionnaires ≥2 or ≥ 3 points for any of the 5 sub-dimensions
* Signature of informed consent

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No