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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03271138 |
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Date of registration:
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30/08/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Bifidobacterium Infantis NLS Super Strain for Celiac Disease Patients on a Gluten-free Diet With Persistent Gastrointestinal Symptoms
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Scientific title:
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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 |
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Date of first enrolment:
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July 21, 2017 |
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Target sample size:
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18 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03271138 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Supportive Care. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 2
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Countries of recruitment
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Argentina
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Contacts
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Name:
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Edgardo Smecuol, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Dr. C. Bonorino Udaondo Gastroenterology Hospital |
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Name:
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Julio C Bai, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Dr. C. Bonorino Udaondo Gastroenterology Hospital |
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Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Celiac Disease
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Intervention(s)
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Other: Placebo
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Dietary Supplement: Bifidobacterium infantis NLS super strain (Natren LIFE START®2)
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Primary Outcome(s)
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Changes in Gastrointestinal Symptom Rating Scale (GSRS)
[Time Frame: Baseline, End of Period I (3 weeks), End of Period II (8 weeks)]
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Secondary Outcome(s)
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Changes in anthropometric measurements (BMI)
[Time Frame: Baseline, End of Period I (3 weeks), End of Period II (8 weeks)]
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Changes in Quality of Life: SF-36
[Time Frame: Baseline, End of Period I (3 weeks), End of Period II (8 weeks)]
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Changes in gut microbiota
[Time Frame: Baseline, End of Period I (3 weeks), End of Period II (8 weeks)]
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Changes in Gluten Immunogenic Peptides (GIP)
[Time Frame: Baseline, End of Period I (3 weeks), End of Period II (8 weeks)]
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Changes in serology (IgA tTG & IgA DGP)
[Time Frame: Baseline, End of Period I (3 weeks), End of Period II (8 weeks)]
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Changes in Celiac Symptoms Index (CSI)
[Time Frame: Baseline, End of Period I (3 weeks), End of Period II (8 weeks)]
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Secondary ID(s)
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001
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GlobalIP
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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