Double-blind, randomised, placebo-controlled intervention trial to evaluate the effects of Bifidobacterium longum CECT 7347 in children with newly diagnosed coeliac disease

Br J Nutr. 2014 Jul 14;112(1):30-40. doi: 10.1017/S0007114514000609. Epub 2014 Apr 28.


Interactions between the immune system and the intestinal microbiota may play a role in coeliac disease (CD). In the present study, the potential effects of Bifidobacterium longum CECT 7347 in children with newly diagnosed CD were evaluated. A double-blind, randomised, placebo-controlled trial was conducted in thirty-three children who received a capsule containing either B. longum CECT 7347 (10⁹ colony-forming units) or placebo (excipients) daily for 3 months together with a gluten-free diet (GFD). Outcome measures (baseline and post-intervention) included immune phenotype of peripheral blood cells, serum cytokine concentration, faecal secretory IgA (sIgA) content, anthropometric parameters and intestinal microbiota composition. Comparisons between the groups revealed greater height percentile increases (P= 0·048) in the B. longum CECT 7347 group than in the placebo group, as well as decreased peripheral CD3⁺ T lymphocytes (P= 0·004) and slightly reduced TNF-α concentration (P= 0·067). Within-group comparisons of baseline and final values did not reveal any differences in T lymphocytes and cytokines in the placebo group, while decreased CD3⁺ (P =0·013) and human leucocyte antigen (HLA)-DR⁺ T lymphocytes (P =0·029) and slightly reduced TNF-α concentration (P= 0·085) were detected in the B. longum CECT 7347 group. Comparison between the groups showed that the administration of B. longum CECT 7347 reduced the numbers of the Bacteroides fragilis group (P= 0·020) and the content of sIgA in stools (P= 0·011) compared with the administration of placebo. Although this is a first exploratory intervention with limitations, the findings suggest that B. longum CECT 7347 could help improve the health status of CD patients who tend to show alterations in gut microbiota composition and a biased immune response even on a GFD.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Anti-Inflammatory Agents, Non-Steroidal / therapeutic use*
  • Bacteroides fragilis / growth & development
  • Bacteroides fragilis / immunology*
  • Bacteroides fragilis / isolation & purification
  • Bifidobacterium* / immunology
  • Celiac Disease / blood
  • Celiac Disease / diet therapy*
  • Celiac Disease / immunology
  • Celiac Disease / microbiology
  • Child
  • Child Development
  • Child, Preschool
  • Combined Modality Therapy
  • Cytokines / blood
  • Diet, Gluten-Free
  • Double-Blind Method
  • Feces / chemistry
  • Feces / microbiology
  • Female
  • Gram-Negative Bacteria / growth & development
  • Gram-Negative Bacteria / immunology
  • Gram-Negative Bacteria / isolation & purification
  • Gram-Positive Bacteria / growth & development
  • Gram-Positive Bacteria / immunology
  • Gram-Positive Bacteria / isolation & purification
  • Humans
  • Immunity, Mucosal*
  • Immunoglobulin A, Secretory / analysis
  • Immunoglobulin A, Secretory / metabolism
  • Intestinal Mucosa / immunology*
  • Intestinal Mucosa / metabolism
  • Intestinal Mucosa / microbiology
  • Male
  • Microbial Viability
  • Probiotics / therapeutic use*


  • Anti-Inflammatory Agents, Non-Steroidal
  • Cytokines
  • Immunoglobulin A, Secretory