Status:
COMPLETED
Bifidobacterium Infantis NLS Super Strain for Celiac Disease Patients on a Gluten-free Diet With Persistent Gastrointestinal Symptoms
Lead Sponsor:
Global Institute of Probiotics
Collaborating Sponsors:
Dr. C. Bonorino Udaondo Gastroenterology Hospital
Research Institute, Universidad del Salvador
Conditions:
Celiac Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 stra...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 21 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 7 2017
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT03271138
Start Date
July 21 2017
End Date
December 7 2017
Last Update
August 24 2018
Active Locations (1)
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1
Small Bowel Section, Department of Medicine, Dr. C. Bonorino Udaondo Gastroenterology Hospital
Buenos Aires, Argentina