- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03271138
Bifidobacterium Infantis NLS Super Strain for Celiac Disease Patients on a Gluten-free Diet With Persistent Gastrointestinal Symptoms
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 Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Buenos Aires, Argentina
- Small Bowel Section, Department of Medicine, Dr. C. Bonorino Udaondo Gastroenterology Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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 |
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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.
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2 capsules, 3 times per day, for daily total of 12x10^9 CFU Bifidobacterium infantis NLS super strain
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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.
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2 capsules, 3 times per day, containing rice flour, hydroxypropyl and methylcellulose
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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)
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Baseline, End of Period I (3 weeks), End of Period II (8 weeks)
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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)
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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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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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16S rRNA Illumina based sequencing
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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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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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Baseline, End of Period I (3 weeks), End of Period II (8 weeks)
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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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Baseline, End of Period I (3 weeks), End of Period II (8 weeks)
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Collaborators and Investigators
Sponsor
Collaborators
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
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GlobalIP
- 001 (NavyGHB)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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