NCT03271138

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

Completed Phase 2 Last updated 24 August 2018

What this trial tests

Phase 2 trial testing Bifidobacterium infantis NLS super strain (Natren LIFE START®2) in Celiac Disease in 18 participants. Completed in 7 December 2017.

Timeline

21 July 2017

Primary endpoint
7 December 2017

7 December 2017

Quick facts

Lead sponsor	Global Institute of Probiotics
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	quadruple
Primary purpose	supportive care
Enrollment	18
Start date	21 July 2017
Primary completion	7 December 2017
Estimated completion	7 December 2017
Sites	1 location across Argentina

Drugs / interventions tested

• Bifidobacterium infantis NLS super strain (Natren LIFE START®2)
• Placebo

Conditions studied

• Celiac Disease — all drugs for Celiac Disease →

Sponsor

Global Institute of Probiotics

Who can join

18 and older, any sex, with Celiac Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Gliadin Sequestration as a Novel Therapy for Celiac Disease: A Prospective Application for Polyphenols.
   Van Buiten CB, Elias RJ. · · 2021 · cited 14× · PMID 33435615 · DOI 10.3390/ijms22020595
2. Effect of <i>Bifidobacterium infantis</i> NLS super strain in symptomatic coeliac disease patients on long-term gluten-free diet - an exploratory study.
   Smecuol E, Constante M, Temprano MP, Costa AF, et al · · 2020 · cited 14× · PMID 33032471 · DOI 10.3920/bm2020.0016
3. Celiac Disease and Non-celiac Wheat Sensitivity: State of Art of Non-dietary Therapies.
   Serena G, D'Avino P, Fasano A. · · 2020 · cited 13× · PMID 33015123 · DOI 10.3389/fnut.2020.00152
4. Is There a Future Without Gluten Restrictions for Celiac Patients? Update on Current Treatments.
   Girbal-González M, Pérez-Cano FJ. · · 2025 · cited 2× · PMID 41010485 · DOI 10.3390/nu17182960