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

Celiac Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03271138
• Other study ID #: GlobalIP
• Secondary ID: 001
• Status: Completed
• Phase: Phase 2
• Start date: July 21, 2017
• Est. completion date: December 7, 2017

Study information

• Verified date: August 2018
• Source: Global Institute of Probiotics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: December 7, 2017
• Est. primary completion date: December 7, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Celiac Disease

Intervention

Dietary Supplement:
• Bifidobacterium infantis NLS super strain (Natren LIFE START®2)
2 capsules, 3 times per day, for daily total of 12x10^9 CFU Bifidobacterium infantis NLS super strain

Other:
• Placebo
2 capsules, 3 times per day, containing rice flour, hydroxypropyl and methylcellulose

Locations

Country	Name	City	State
Argentina	Small Bowel Section, Department of Medicine, Dr. C. Bonorino Udaondo Gastroenterology Hospital	Buenos Aires

Sponsors (4)

Lead Sponsor	Collaborator
Global Institute of Probiotics	Consejo de Investigaciones en Salud, Ministerio de Salud, Gobierno Autónomo de Buenos Aires, Dr. C. Bonorino Udaondo Gastroenterology Hospital, Research Institute, Universidad del Salvador

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Gastrointestinal Symptom Rating Scale (GSRS)		Baseline, End of Period I (3 weeks), End of Period II (8 weeks)
Secondary	Changes in Celiac Symptoms Index (CSI)		Baseline, End of Period I (3 weeks), End of Period II (8 weeks)
Secondary	Changes in Quality of Life: SF-36		Baseline, End of Period I (3 weeks), End of Period II (8 weeks)
Secondary	Changes in gut microbiota	16S rRNA Illumina based sequencing	Baseline, End of Period I (3 weeks), End of Period II (8 weeks)
Secondary	Changes in Gluten Immunogenic Peptides (GIP)		Baseline, End of Period I (3 weeks), End of Period II (8 weeks)
Secondary	Changes in serology (IgA tTG & IgA DGP)		Baseline, End of Period I (3 weeks), End of Period II (8 weeks)
Secondary	Changes in anthropometric measurements (BMI)		Baseline, End of Period I (3 weeks), End of Period II (8 weeks)