A Phase I Study to Assess Safety and Tolerability of a Live Biotherapeutic Product (SVT-1B149) in the treatment of Chronic Functional Constipation in Adult Participants.

Servatus Ltd0 个研究点目标入组 38 人开始时间: 2020年10月19日最近更新: 2023年1月9日

适应症

试验速览

阶段: 1 期
状态: 已完成
发起方: Servatus Ltd
入组人数: 38

研究概览研究设计入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional
分配方式: Non-randomised trial
主要目的: Treatment
盲法: Open (masking not used)

入排标准

年龄范围: 18 Years 至 o limit（—）
性别: All

入选标准

•Male and female Participants aged 18 years or older, capable of providing informed consent and able to attend the Princess Alexandra Hospital as required for the study;
•Determined by medical history, physical examination, vital signs and clinical judgement of the Investigator to be medically healthy and eligible for inclusion into the study;
•Confirmation of diagnosis of IBS-C or IC according to Rome III criteria;
•Able to adhere to the medication guidelines prior to undertaking the glucose breath test which includes:
•- No antibiotic use 2 weeks prior to the procedure;
•- No smoking or eating any food from 10 pm before the procedure until after the test is finished.
•Females of childbearing potential (FOCBP) must have a negative pregnancy test at the Baseline Visit. While on the study, FOCBP who engage in activity in which conception is possible, must use one of the approved contraceptive options described below:
•I.Hormonal contraception (oral, injection, implant, transdermal patch, vaginal ring);
•II.Intrauterine device (IUD);
•III.Tubal Ligation;
•IV.Partner’s Vasectomy; or
•V.Barrier method i.e. male or female condom.
•Male Participants who have not had a vasectomy and who engage in activity in which conception is possible, must use barrier contraception i.e. male condom while on study, or if their partner is FOCBP, the partner can use hormonal contraception, an IUD or have had a tubal ligation.

排除标准

•Participants who meet any of the following criteria will be ineligible for enrolment into the study:
•Diarrhoea predominant or alternating IBS;
•Immunocompromised Participants, or those with known or suspected history of immunodeficiency, as determined by medical history review, physical examination and/or laboratory findings;
•History of severe adverse reaction including but not limited to anaphylaxis (or a suspicion of this by the Investigator) to any products containing bacterial species, any component of SVT-1B149 or to any antibiotic commonly used to treat bacterial infections;
•Any history of anti-tumour necrosis factor (TNF) treatment or other immunosuppressant medications;
•Current use of corticosteroids: Greater than or equal to 15mg/daily or oral prednisolone (or equivalent) and/or history of intermittent corticosteroid usage of greater than or equal to 40mg/daily or oral prednisolone (or equivalent) of greater than 3 days in the last 3 months;
•Use of oral antibiotics within 2 weeks of the Baseline Visit (Day 0) and for the study duration;
•Females who are pregnant or breastfeeding or planning on becoming pregnant for the study period (treatment and follow-up periods);
•Any condition that, in the opinion of the Investigator, contraindicates participation in this study or poses an additional risk to the Participant including any known and/or suspected medical or psychiatric conditions, history of active peptic ulcer disease and/or gastroesophageal disease, severe gastritis or presence of alarm symptoms.

研究者

发起方

Servatus Ltd

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