Untersuchung Des Einflusses Einer Tryptophanreichen Diät Auf Das Therapeutische Potential Von Probiotika Nach Antibiotischer Therapie Bei Chronischer Pouchitis (Try Pro Pouch). Eine Prospektive Randomisierte Kontrollierte Doppelblinde Interventionsstudie
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 主要终点
- Increase of the proportion of FoxP3+ CD4+ T cells in gut biopsies
研究概览
简要总结
Patients with a pouch frequently suffer from chronic inflammation of the intestinal tract, called pouchitis. Pouchitis is routienly treated with repeated courses of antibiotics and probiotics, which does not stop the inflammation from recurring and exposes the patients to the risk of developing antibiotic -resistant pouchitis. Experimental data suggest that the effectiveness of the antibiotic and probiotic treatment can be prolonged by high consumption of trypotophan, an aminoacid present in everyday food. The Try Pro Pouch study aims to compare the consumption of high amounts of tryptophan against placebo in patients with pouchitis.
详细描述
Participants with chronic pouchitis receive either a weight adapted supplement containing etiher trypotophan or a placebo after completing the standard treatment with antibiotics or probiotics for their pouchitis. Endoskopy will be performed, stool and blood will be sampled, symptoms will be monitored.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
care providers, Investigators and Outcome Assessors are blinded.
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
- •Pouchitis (PDAI >= 7)
- •indication for the application of antibiotics and probiotics
- •Age >=18 years
- •Informed consent
排除标准
- •major surgery planned druing the intervention
- •high risk for malnutrition (NRS 2002 >=3/ BMI <18,5 kg/m^2)
研究组 & 干预措施
Placebo
regular treatment of pouchitis with consecutive application of antibiotics and probiotics, followed by placebo.
干预措施: Placebo (Other)
Intervention
regular treatment of pouchitis with consecutive application of antibiotics and probiotics, additional supplementation of tryptophan (25mg/kg bodyweight)
干预措施: Tryptophan 25mg/kg bodyweight (Dietary Supplement)
结局指标
主要结局
Increase of the proportion of FoxP3+ CD4+ T cells in gut biopsies
时间窗: from enrollent to end of treatment at 12 weeks
Biopsies of individuals receiving tryptophan or placebot will be analysed by Flow-Cytometry or sequencing. We aim to detect an lasting increase of the proportion of FoxP3+ CD4+ T cells in the mucosa of individuals receiving tryptophan, but not in those receiving placebo.
次要结局
- Increase of the frequency of Lactobacilli and Bifidobacilli in the gut microbiota(from enrollent to end of treatment at 12 weeks)
- Increase of 3-IPA-levels in blood and stool(from enrollent to end of treatment at 12 weeks)
- Higher rates of therapeutic response defined by PDAI(from enrollent to end of treatment at 12 weeks)
- Decreased number of prescribed antibiotics druing follow-up(from enrollent to end of observation at 52 weeks)