NCT05845073已完成不适用
A Pilot Clinical Trial Assessing the Effect of Probiotic Supplementation on Antibiotic Associated Gastrointestinal Symptoms and Quality of Life
The Archer-Daniels-Midland Company2 个研究点 分布在 1 个国家目标入组 69 人开始时间: 2023年5月9日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 69
- 试验地点
- 2
- 主要终点
- Change in the Gastrointestinal Symptom Rating Score - Irritable Bowel Syndrome (GSRS-IBS)
研究概览
简要总结
This study evaluates the effect of a multistrain probiotic on gastrointestinal (GI) complaints and diarrhoea in subjects receiving short-term antibiotic (AB) treatment
详细描述
This study aims to investigate the safety and efficacy of live bacteria on gastrointestinal (GI) complaints and diarrhoea in subjects receiving short-term antibiotic (AB) treatment. The trial will be run in Germany and will recruit adult men and women.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females ≥ 18 years and ≤65 years old
- •Body Mass Index 18.5-30 kg/m2
- •Generally in good health
- •Use of broad spectrum orally administered AB(s) for no more than 24h prior to V1 (penicillins, cephalosporins, quinolones, tetracyclines and lincomycins) for diagnosed infections other than those of GI, urinary or reproductive tract not requiring hospitalization, with a foreseen total duration of AB intake of 5-7 days
- •Having access to a smartphone/tablet or a computer with an internet access, and familiar with the use thereof (checked during the visit)
- •Readiness to keep dietary habits during the study
- •Readiness to avoid the use of any nutritional (e. g. prebiotic, probiotic), medical and further interventional options for management of GI complaints/diarrhoea (beyond the IP) during the study
- •Women of childbearing potential:
- •commitment to use contraception methods
- •negative pregnancy testing (beta human chorionic gonadotropin test in urine) at V1
排除标准
- •More than 24h from the first dose of AB for diagnosed infections (as per inclusion criterion 4) until screening
- •Intravenously administered antibiotics
- •Taking AB in the last 30 days before starting current AB treatment
- •Taking any probiotic or prebiotic supplements in the last 30 days prior to screening
- •Using antidiarrheal medications / enemas on regular basis
- •Multimedication with microbiome-impacting medications within 30 days before enrolment (e.g. proton pump inhibitors antivirals/immunosuppressants, antidepressants)
- •Clinically relevant (as per investigator judgement) self-reported chronic diseases of GI tract (e.g. inflammatory bowel syndrome, Crohn's disease, ulcerative colitis, celiac disease, diverticulitis, idiopathic esophageal reflux, malabsorption disorder, severe constipation), urinary tract, reproductive tract (e.g. endometriosis, adenomyosis, pelvic inflammatory disease, uterine fibroids) or metabolic (diabetes (type 1 or Type 2), familial hypercholestraemia, hereditary haemachromatosis) diseases
- •Any form of bowel preparation for endoscopy used in the last 3 months
- •Recent GI surgery (within the last 6 months)
- •Women of child-bearing potential: pregnancy, recently gave birth (within the last 6 months) and/or nursing
- •Recent Covid-19 infection (less than 4 weeks since the first negative SARS-CoV-2 (self) test after the infection)
- •Specific dietary restrictions (e.g. active phase of low Fermentable Oligosaccharides, Disaccharides, Monosaccharides and Polyols (FODMAP) diet)
- •Any dietary mode excluding passage of food via GI tract
- •High intake of alcohol (male subjects > 14 units per week, female subjects, >11 (1 unit corresponds to 360 mL beer, 45 mL spirits (40% alcohol) or 150 mL wine)
- •History of confirmed Clostridium difficile infection in the last 6 months
- •Known allergy or hypersensitivity to any ingredients of the IP
- •Previous adverse reactions to antibiotics
- •Artificial or damaged heart valves
- •History and/or presence of other clinically significant known (self-reported) condition/ disorder, which per investigator's judgement could interfere with the results of the study or the safety of the subject, e.g.:
- •acute pancreatitis
- •immunodeficiency
- •eating disorder
- •recurrent diarrhoea
- •History of or current abuse of drugs or medication
- •Inability to comply with study requirements
- •Subjects who are deprived of their freedom by administrative or legal decision or who are in guardianship
- •Participation in another clinical study in the 30 days prior to V1 and during the study
结局指标
主要结局
Change in the Gastrointestinal Symptom Rating Score - Irritable Bowel Syndrome (GSRS-IBS)
时间窗: Baseline (V1), Day 6 - 11 (V2)
Change in Gastrointestinal Symptom Rating Score - Irritable Bowel Syndrome total score (max 78) from baseline (V1) to Day 6 - 11 (V2), where higher scores mean worse symptoms
次要结局
- Metabolomic Analysis of Faecal Samples(Baseline (V1), Day 6 - 11 (V2), Day 20 - 25 (V3))
- Difference in the Gastrointestinal Symptom Rating Score - Irritable Bowel Syndrome (GSRS-IBS)(Baseline (V1), Day 20 - 25 (V3))
- Incidence of antibiotic-associated diarrhoea (AAD)(Through study completion, an expected average of 21 days)
- Duration of antibiotic associated diarrhoea (AAD)(Through study completion, an expected average of 21 days)
- Difference in Stool Consistency(Through study completion, an expected average of 21 days)
- Difference in Short Form 12 (SF-12) - Mental Component Score(Day 6 - 11 (V2), Day 20 - 25 (V3))
- Difference in Short Form 12 (SF-12) - Physical Component Score(Day 6 - 11 (V2), Day 20 - 25 (V3))
- Difference in Short Form 12 (SF-12) - Mental Component Score (MCS)(Baseline (V1), Day 6 - 11 (V2), Day 20 - 25 (V3))
- Duration of diarrhoea(Through study completion, an expected average of 21 days)
- Difference in individual scores of Gastrointestinal Symptom Rating Score - Irritable Bowel Syndrome (GSRS-IBS)(Baseline (V1), Day 6 - 11 (V2), Day 20 - 25 (V3))
- Difference in Stool Frequency(Through study completion, an expected average of 21 days)
- Percentage with diarrhoea(Through study completion, an expected average of 21 days)
- Difference in Short Form 12 (SF-12) - Physical Component Score (PCS)(Baseline (V1), Day 6 - 11 (V2), Day 20 - 25 (V3))
研究者
研究点 (2)
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