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

Primary Purpose

Celiac Disease

Status

Completed

Phase

Phase 2

Locations

Argentina

Study Type

Interventional

Intervention

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

Placebo

About this trial

This is an interventional supportive care trial for Celiac Disease focused on measuring Celiac Disease, Gluten-Free Diet, Bifidobacterium infantis NLS super strain, gastrointestinal symptoms, quality of life, microbiota, IgA TTG, IgA DGP

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Small Bowel Section, Department of Medicine, Dr. C. Bonorino Udaondo Gastroenterology Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Bifidobacterium Infantis NLS Super Strain

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Changes in Gastrointestinal Symptom Rating Scale (GSRS)

Secondary Outcome Measures

Changes in Celiac Symptoms Index (CSI)

Changes in Quality of Life: SF-36

Changes in gut microbiota

16S rRNA Illumina based sequencing

Changes in Gluten Immunogenic Peptides (GIP)

Changes in serology (IgA tTG & IgA DGP)

Changes in anthropometric measurements (BMI)

Full Information

NCT ID

NCT03271138

First Posted

August 30, 2017

Last Updated

August 23, 2018

Sponsor

Global Institute of Probiotics

Collaborators

Dr. C. Bonorino Udaondo Gastroenterology Hospital, Research Institute, Universidad del Salvador, Consejo de Investigaciones en Salud, Ministerio de Salud, Gobierno Autónomo de Buenos Aires

1. Study Identification

Unique Protocol Identification Number

NCT03271138

Brief Title

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

Official Title

A Randomized Controlled Trial of Dietary Supplementation With Bifidobacterium Infantis NLS Super Strain Among Celiac Disease Patients on a Gluten-free Diet With Persistent Gastrointestinal Symptoms

Study Type

Interventional

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Completed

Study Start Date

July 21, 2017 (Actual)

Primary Completion Date

December 7, 2017 (Actual)

Study Completion Date

December 7, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Global Institute of Probiotics

Collaborators

Dr. C. Bonorino Udaondo Gastroenterology Hospital, Research Institute, Universidad del Salvador, Consejo de Investigaciones en Salud, Ministerio de Salud, Gobierno Autónomo de Buenos Aires

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Celiac Disease

Keywords

Celiac Disease, Gluten-Free Diet, Bifidobacterium infantis NLS super strain, gastrointestinal symptoms, quality of life, microbiota, IgA TTG, IgA DGP

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

18 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Bifidobacterium Infantis NLS Super Strain

Arm Type

Active Comparator

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Dietary Supplement

Intervention Name(s)

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

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Changes in Gastrointestinal Symptom Rating Scale (GSRS)

Time Frame