Clinical trial NCT03271138: Bifidobacterium Infantis NLS Super Strain for Celiac Disease Patients on a Gluten-free Diet With Persistent Gastrointestinal Symptoms
Official title: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Celiac Disease
Keywords: Celiac Disease
Gluten-Free Diet
Bifidobacterium infantis NLS super strain
gastrointestinal symptoms
quality of life
microbiota
IgA TTG
IgA DGP
Lead sponsor: Global Institute of Probiotics
Sponsor class: OTHER
Collaborators: name: Dr. C. Bonorino Udaondo Gastroenterology Hospital
name: Research Institute, Universidad del Salvador
name: Consejo de Investigaciones en Salud, Ministerio de Salud, Gobierno Autónomo de Buenos Aires
First posted: 2017-09-01
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in Gastrointestinal Symptom Rating Scale (GSRS)
timeFrame: Baseline, End of Period I (3 weeks), End of Period II (8 weeks)
Secondary outcomes:
measure: Changes in Celiac Symptoms Index (CSI)
timeFrame: Baseline, End of Period I (3 weeks), End of Period II (8 weeks)
measure: Changes in Quality of Life: SF-36
timeFrame: Baseline, End of Period I (3 weeks), End of Period II (8 weeks)
measure: Changes in gut microbiota
timeFrame: Baseline, End of Period I (3 weeks), End of Period II (8 weeks)
measure: Changes in Gluten Immunogenic Peptides (GIP)
timeFrame: Baseline, End of Period I (3 weeks), End of Period II (8 weeks)
measure: Changes in serology (IgA tTG & IgA DGP)
timeFrame: Baseline, End of Period I (3 weeks), End of Period II (8 weeks)
measure: Changes in anthropometric measurements (BMI)
timeFrame: Baseline, End of Period I (3 weeks), End of Period II (8 weeks)
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Small Bowel Section, Department of Medicine, Dr. C. Bonorino Udaondo Gastroenterology Hospital
Study officials:
affiliation: Dr. C. Bonorino Udaondo Gastroenterology Hospital
name: Edgardo Smecuol, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dr. C. Bonorino Udaondo Gastroenterology Hospital
name: Julio C Bai, MD
role: STUDY_DIRECTOR
References:
citation: 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.