A prospective, open label, randomized, comparative, proof of science, clinical safety and efficacy study of novel Synbiotic (ByRx) in children having antibiotic associated dysbiosis

Inzpera health Science Limited1 个研究点分布在 1 个国家目标入组 32 人开始时间: 2025年4月1日最近更新: 2025年3月21日

试验速览

阶段: 不适用
状态: 已完成
发起方
入组人数: 32
试验地点: 1
主要终点: To evaluate the effectiveness of the test product in terms of change in

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This is a prospective, open-label, randomized, comparative, proof-of-concept study evaluating the clinical safety and efficacy of a novel synbiotic treatment in children with antibiotic-associated dysbiosis.

The study will be conducted in two cohorts:

· Cohort 1**:** A total of 12 patients (6 per arm) will participate. Six patients will receive antibiotics alone, while the other six will receive antibiotics combined with the synbiotic for 5 days. For the synbiotic arm, Days 6 and 7 will involve synbiotic administration only.

· Cohort 2**:** If the results from Cohort 1 are satisfactory, an additional up to 32 (16 subjects per arm) will be enrolled.

The subjects will be instructed to visit the facility as per the below visits.

Visit 01 (Day 01): Screening, ICD, Enrolment, Stool Sample Collection, Antibiotic treatment 5 Days antibiotic period

Visit 02 (Day 06): Stool Sample Collection, test treatment period

Visit 03 (Day 11 to Day 14 ): Test Treatment stop, Stool Sample Collection, End of The Study

研究设计

研究类型: Interventional
分配方式: Randomized
盲法: None

入排标准

年龄范围: 2.00 Year(s) 至 12.00 Year(s)（—）
性别: All

入选标准

•Age: 02 to 12 years (both inclusive) at the time of consent.
•Sex: male and females.
•Subjects having symptoms of URTI or gastro infection (dysbiosis) which includes burning sensation, bloating, nausea, altered bowel habit, digestion issues, and high tendency of falling sick, chronic fatigue, constipation, diarrhoea etc.
•Willing to give written parental informed consent and are willing to come for regular follow-up on the study site.
•Who commit not to use other probiotics, synbiotic, prebiotics, and anti-biotic for their child other than the test product for the entire duration of the study.
•Subject who has not participated in a similar investigation in the past three months.
•Willing to use test product throughout the study period 8) subject having refrigerator at home.

排除标准

•1.Subjects with suspected or confirmed organic causes of constipation (e.g., Hirschsprung’s disease, hypothyroidism, structural anal anomalies).
•2.Subjects with an allergic response to any prebiotic, probiotic, or synbiotic product.
•3.Subjects on chronic medication (e.g., aspirin, anti-inflammatories, antihistamines, corticosteroids) that may affect study outcomes.
•4.Subjects with major diseases in cardiovascular, renal, hepatic, gastrointestinal, pulmonary, or endocrine systems.
•5.History of alcohol or drug addiction.
•6.Subjects with a history of major gastrointestinal complications (e.g., Crohn’s disease, ulcers, cancer, ulcerative colitis).
•7.Subjects participating in similar trials within the last four weeks.