Testing safety of a live bacterial therapy for the treatment of Chronic Constipation
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 Ltd
35 participants
Feb 23, 2021
Interventional
Conditions
Summary
The aim of this study is to evaluate safety and tolerability of SVT-1B149 as a treatment for chronic functional constipation together with preliminary efficacy. The treatment consists of carefully selected bacterial species. Bacteria are naturally found in the digestive tract and are a research focus for their important role in many conditions related to gut health. Bacteria play an important role in the function of the immune system, digestive health, inflammation and have anti-microbial properties. Several research studies have found treatment with beneficial bacteria to relieve constipation and related symptoms. This study will help determine how safe and effective SVT-1B149 is as a stand-alone therapy in treating constipation and reducing symptoms.
Eligibility
Inclusion Criteria13
- 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.
Exclusion Criteria9
- 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.
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Interventions
The overall study duration consists of a total of 12 weeks consisting of 8 weeks of intervention (treatment) and an additional 4 weeks as an observation period (no treatment). Participants will be provided with 5 x 250ml bottles in total, 3 bottles at Baseline and 2 bottles at Week 4, containing the investigational medicine. Participants will carefully measure out and orally consume 10 mLs of the investigational product SVT-1B149, twice daily for 8 Weeks. Each 10 mL dose of SVT-1B149 contains 1.5 x 10^10 (15 billion) colony forming units (CFU) of bacterial species. 10 mLs of product will be consumed in the morning and evening with food, with the participants required to record each dose taken. Participants will record their adherence to the intervention in a participant diary, along with all bowel movements, any adverse events and any concomitant medications taken during the study period. At the end of Week 4 participants will return to the clinic for assessment and to review their study diary. Participants will be required to return the 2 empty medication bottles to account for any missed doses. They will be provided two new bottles of study medication. The participants will be provided a second diary for the following 4 weeks and they will continue to record their adherence to the intervention, along with all bowel movements, any adverse events and any concomitant medications taken during the study period. At the end of the 8 Weeks, participants will return the remaining 3 medication bottles to the study coordinator to account for missed doses, if any. The participants will be provided a third diary for the following 4 Weeks and they will continue to record any adverse events in the diary following the study period. They will not consume the study medication during this 4 week period.
Locations(1)
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ACTRN12620001077954