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Trial record 11 of 103 for:    celiac disease | Recruiting, Not yet recruiting, Available Studies

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

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ClinicalTrials.gov Identifier: NCT03271138
Recruitment Status : Recruiting
First Posted : September 1, 2017
Last Update Posted : September 1, 2017
Sponsor:
Collaborators:
Dr. C. Bonorino Udaondo Gastroenterology Hospital
Research Institute, Universidad del Salvador
Consejo de Investigaciones en Salud, Ministerio de Salud, Gobierno Autónomo de Buenos Aires
Information provided by (Responsible Party):
Global Institute of Probiotics

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.

Condition or disease Intervention/treatment Phase
Celiac Disease Dietary Supplement: Bifidobacterium infantis NLS super strain (Natren LIFE START®2) Other: Placebo Phase 2

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
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
Estimated Study Start Date : August 2017
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Celiac Disease

Arm Intervention/treatment
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.
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

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




Primary Outcome Measures :
  1. Changes in Gastrointestinal Symptom Rating Scale (GSRS) [ Time Frame: Baseline, End of Period I (3 weeks), End of Period II (8 weeks) ]

Secondary Outcome Measures :
  1. Changes in Celiac Symptoms Index (CSI) [ Time Frame: Baseline, End of Period I (3 weeks), End of Period II (8 weeks) ]
  2. Changes in Quality of Life: SF-36 [ Time Frame: Baseline, End of Period I (3 weeks), End of Period II (8 weeks) ]
  3. Changes in gut microbiota [ Time Frame: Baseline, End of Period I (3 weeks), End of Period II (8 weeks) ]
    16S rRNA Illumina based sequencing

  4. Changes in Gluten Immunogenic Peptides (GIP) [ Time Frame: Baseline, End of Period I (3 weeks), End of Period II (8 weeks) ]
  5. Changes in serology (IgA tTG & IgA DGP) [ Time Frame: Baseline, End of Period I (3 weeks), End of Period II (8 weeks) ]
  6. Changes in anthropometric measurements (BMI) [ Time Frame: Baseline, End of Period I (3 weeks), End of Period II (8 weeks) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03271138


Contacts
Contact: Edgardo Smecuol, MD +541142064641 esmecuol@intramed.net

Locations
Argentina
Small Bowel Section, Department of Medicine, Dr. C. Bonorino Udaondo Gastroenterology Hospital Recruiting
Buenos Aires, Argentina
Contact: Edgardo Smecuol, MD         
Sponsors and Collaborators
Global Institute of Probiotics
Dr. C. Bonorino Udaondo Gastroenterology Hospital
Research Institute, Universidad del Salvador
Consejo de Investigaciones en Salud, Ministerio de Salud, Gobierno Autónomo de Buenos Aires
Investigators
Principal Investigator: Edgardo Smecuol, MD Dr. C. Bonorino Udaondo Gastroenterology Hospital
Study Director: Julio C Bai, MD Dr. C. Bonorino Udaondo Gastroenterology Hospital

Responsible Party: Global Institute of Probiotics
ClinicalTrials.gov Identifier: NCT03271138     History of Changes
Other Study ID Numbers: GlobalIP
001 ( Other Grant/Funding Number: Dr. C. Bonorino Udaondo Gastroenterology Hospital )
First Posted: September 1, 2017    Key Record Dates
Last Update Posted: September 1, 2017
Last Verified: August 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Global Institute of Probiotics:
Celiac Disease
Gluten-Free Diet
Bifidobacterium infantis NLS super strain
gastrointestinal symptoms
quality of life
microbiota
IgA TTG
IgA DGP

Additional relevant MeSH terms:
Celiac Disease
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases