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

August 23, 2018 updated by: Global Institute of Probiotics

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

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Buenos Aires, Argentina
        • Small Bowel Section, Department of Medicine, Dr. C. Bonorino Udaondo Gastroenterology Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 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.
2 capsules, 3 times per day, for daily total of 12x10^9 CFU Bifidobacterium infantis NLS super strain
PLACEBO_COMPARATOR: 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.
2 capsules, 3 times per day, containing rice flour, hydroxypropyl and methylcellulose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in Gastrointestinal Symptom Rating Scale (GSRS)
Time Frame: Baseline, End of Period I (3 weeks), End of Period II (8 weeks)
Baseline, End of Period I (3 weeks), End of Period II (8 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Celiac Symptoms Index (CSI)
Time Frame: Baseline, End of Period I (3 weeks), End of Period II (8 weeks)
Baseline, End of Period I (3 weeks), End of Period II (8 weeks)
Changes in Quality of Life: SF-36
Time Frame: Baseline, End of Period I (3 weeks), End of Period II (8 weeks)
Baseline, End of Period I (3 weeks), End of Period II (8 weeks)
Changes in gut microbiota
Time Frame: Baseline, End of Period I (3 weeks), End of Period II (8 weeks)
16S rRNA Illumina based sequencing
Baseline, End of Period I (3 weeks), End of Period II (8 weeks)
Changes in Gluten Immunogenic Peptides (GIP)
Time Frame: Baseline, End of Period I (3 weeks), End of Period II (8 weeks)
Baseline, End of Period I (3 weeks), End of Period II (8 weeks)
Changes in serology (IgA tTG & IgA DGP)
Time Frame: Baseline, End of Period I (3 weeks), End of Period II (8 weeks)
Baseline, End of Period I (3 weeks), End of Period II (8 weeks)
Changes in anthropometric measurements (BMI)
Time Frame: Baseline, End of Period I (3 weeks), End of Period II (8 weeks)
Baseline, End of Period I (3 weeks), End of Period II (8 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Edgardo Smecuol, MD, Dr. C. Bonorino Udaondo Gastroenterology Hospital
  • Study Director: Julio C Bai, MD, Dr. C. Bonorino Udaondo Gastroenterology Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 21, 2017

Primary Completion (ACTUAL)

December 7, 2017

Study Completion (ACTUAL)

December 7, 2017

Study Registration Dates

First Submitted

August 30, 2017

First Submitted That Met QC Criteria

August 31, 2017

First Posted (ACTUAL)

September 1, 2017

Study Record Updates

Last Update Posted (ACTUAL)

August 24, 2018

Last Update Submitted That Met QC Criteria

August 23, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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