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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Changes in Gastrointestinal Symptom Rating Scale (GSRS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Bifidobacterium infantis NLS super strain (Natren LIFE START®2) (Dietary Supplement)
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.
干预措施: Placebo (Other)
结局指标
主要结局
Changes in Gastrointestinal Symptom Rating Scale (GSRS)
时间窗: Baseline, End of Period I (3 weeks), End of Period II (8 weeks)
次要结局
- Changes in Celiac Symptoms Index (CSI)(Baseline, End of Period I (3 weeks), End of Period II (8 weeks))
- Changes in Quality of Life: SF-36(Baseline, End of Period I (3 weeks), End of Period II (8 weeks))
- Changes in gut microbiota(Baseline, End of Period I (3 weeks), End of Period II (8 weeks))
- Changes in Gluten Immunogenic Peptides (GIP)(Baseline, End of Period I (3 weeks), End of Period II (8 weeks))
- Changes in serology (IgA tTG & IgA DGP)(Baseline, End of Period I (3 weeks), End of Period II (8 weeks))
- Changes in anthropometric measurements (BMI)(Baseline, End of Period I (3 weeks), End of Period II (8 weeks))