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

NCT03271138 | Completed Phase 2

• 2 other identifiers: GlobalIP001
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Celiac Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Changes in Gastrointestinal Symptom Rating Scale (GSRS)

  Baseline, End of Period I (3 weeks), End of Period II (8 weeks)

Secondary Outcomes (6)

• Changes in Celiac Symptoms Index (CSI)

  Baseline, End of Period I (3 weeks), End of Period II (8 weeks)

• Changes in Quality of Life: SF-36

  Baseline, End of Period I (3 weeks), End of Period II (8 weeks)

• Changes in gut microbiota

  Baseline, End of Period I (3 weeks), End of Period II (8 weeks)

• Changes in Gluten Immunogenic Peptides (GIP)

  Baseline, End of Period I (3 weeks), End of Period II (8 weeks)

• Changes in serology (IgA tTG & IgA DGP)

  Baseline, End of Period I (3 weeks), End of Period II (8 weeks)

Study Arms (2)

Bifidobacterium Infantis NLS Super Strain

ACTIVE COMPARATOR

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.

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

Placebo

PLACEBO COMPARATOR

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.

Other: Placebo

Interventions

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

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

Bifidobacterium Infantis NLS Super Strain

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Global Institute of Probiotics: lead
• Dr. C. Bonorino Udaondo Gastroenterology Hospital: collaborator
• Research Institute, Universidad del Salvador: collaborator
• Consejo de Investigaciones en Salud, Ministerio de Salud, Gobierno Autónomo de Buenos Aires: collaborator

Study Sites (1)

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

Buenos Aires, Argentina

Location

Related Publications (1)

• Smecuol E, Constante M, Temprano MP, Costa AF, Moreno ML, Pinto-Sanchez MI, Vazquez H, Stefanolo JP, Gonzalez AF, D'Adamo CR, Niveloni SI, Maurino E, Verdu EF, Bai JC. Effect of Bifidobacterium infantis NLS super strain in symptomatic coeliac disease patients on long-term gluten-free diet - an exploratory study. Benef Microbes. 2020 Oct 12;11(6):527-534. doi: 10.3920/BM2020.0016. Epub 2020 Oct 9.

  PMID: 33032471 DERIVED

MeSH Terms

Conditions

Celiac Disease

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Edgardo Smecuol, MD

  Dr. C. Bonorino Udaondo Gastroenterology Hospital

  PRINCIPAL INVESTIGATOR

• Julio C Bai, MD

  Dr. C. Bonorino Udaondo Gastroenterology Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2017
• First Posted: September 1, 2017
• Study Start: July 21, 2017
• Primary Completion: December 7, 2017
• Study Completion: December 7, 2017
• Last Updated: August 24, 2018

Record last verified: 2018-08

Locations

AR (1)