bifidobacterium infantis nls super strain for celiac disease patients on a gluten-free diet with persistent gastrointestinal symptoms

Conditions: Celiac Disease

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.

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

Keywords: celiac disease gluten-free diet bifidobacterium infantis nls super strain gastrointestinal symptoms quality of life microbiota iga ttg iga dgp