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Trial registered on ANZCTR


Registration number
ACTRN12620001077954
Ethics application status
Approved
Date submitted
18/09/2020
Date registered
19/10/2020
Date last updated
16/12/2022
Date data sharing statement initially provided
19/10/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Testing safety of a live bacterial therapy for the treatment of Chronic Constipation
Scientific title
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.
Secondary ID [1] 301782 0
None
Universal Trial Number (UTN)
U1111-1258-4070
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Functional Constipation (FC) 318250 0
Irritable Bowel Syndrome - Constipation (IBS-C) 318251 0
Idiopathic Constipation (IC) 318252 0
Condition category
Condition code
Oral and Gastrointestinal 316261 316261 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 318080 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 324444 0
To evaluate the safety and tolerability of twice daily oral consumption of SVT-1B149 in adult participants confirmed to have functional constipation, but who are otherwise healthy. Assessed by incidence of treatment emergent adverse events (TEAEs), discontinuations due to adverse events (AEs) determined from participant diaries and systemic tolerability based on vital signs, - Blood Pressure and Heart Rate measured by using a sphygmomanometer, - Temperature measured with a thermometer - Respiratory rate counted by the Investigator based on number of times the chest rises in 1 minute with participant in Supine position. Examples of known/possible adverse reactions/events: Human safety and efficacy studies have not yet been conducted with the specific combination of bacteria present in SVT-1B149, however their individual safety for human consumption is well recognised and documented. Each species has a Risk Group 1 Classification in that they are not associated with disease in healthy adults and all have been granted the Qualified Presumption of Safety (QPS) status by the European Food Safety Authority (EFSA). Potential adverse events that participants may experience include mild gastrointestinal symptoms including abdominal discomfort, bloating, flatulence and/or nausea.
Timepoint [1] 324444 0
(Day 0) Baseline, Week 4 (mid treatment), Week 8 (end of treatment), Week 12 (4 weeks post treatment)
Primary outcome [2] 325159 0
To evaluate the safety and tolerability of twice daily oral consumption of SVT-1B149 in adult participants confirmed to have functional constipation, but who are otherwise healthy. Assessed by laboratory abnormalities of blood haematological (complete blood count), biochemical parameters and Liver Function Tests (LFT).
Timepoint [2] 325159 0
(Day 0) Baseline and Week 8 (end of treatment)
Secondary outcome [1] 384666 0
To evaluate the efficacy of twice daily oral consumption of SVT-1B149 in adult participants confirmed to have functional constipation, but who are otherwise healthy.
Efficacy of the intervention will be assessed by the PAC-SYM questionnaire and response based on an increase/decrease of the PAC-SYM score. The PAC-SYM measures the severity of symptoms such as stomach pain, bloating, cramps and bowel movements.
Timepoint [1] 384666 0
(Day 0) Baseline, Week 4 (mid treatment), Week 8 (end of treatment) and Week 12 (4 weeks post treatment)
Secondary outcome [2] 384670 0
To evaluate the efficacy in improving symptoms with twice daily oral consumption of SVT-1B149 in adult participants confirmed to have functional constipation, but who are otherwise healthy.
Change in constipation associated symptom will be assessed based on reporting in participant diary.
Timepoint [2] 384670 0
(Day 0) Baseline, Week 4 (mid treatment), Week 8 (end of treatment) and Week 12 (4 weeks post treatment)
Secondary outcome [3] 384791 0
To evaluate the efficacy in improving Quality of Life with twice daily oral consumption of SVT-1B149 in adult participants confirmed to have functional constipation, but who are otherwise healthy.
Change in quality of life will be assessed using the PAC-QOL questionnaire and response based on a increase/decrease of the PAC-QOL score.
Timepoint [3] 384791 0
(Day 0) Baseline, Week 4 (mid treatment), Week 8 (end of treatment) and Week 12 (4 weeks post treatment)
Secondary outcome [4] 384793 0
To assess a change in methanogenic bacteria in response to twice daily oral consumption of SVT-1B149 in adult participants confirmed to have functional constipation, but who are otherwise healthy.
Change in methanogenic bacteria will be measured by a glucose breath test (GBT) and response will be based on a increase/decrease of the GBT value.
Timepoint [4] 384793 0
(Day 0) Baseline and Week 8 (end of treatment)

Eligibility
Key inclusion criteria
• 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/02/2021
Actual
23/02/2021
Date of last participant enrolment
Anticipated
29/07/2022
Actual
6/12/2021
Date of last data collection
Anticipated
31/10/2022
Actual
3/04/2022
Sample size
Target
35
Accrual to date
Final
38
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 17083 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 30757 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 306214 0
Commercial sector/Industry
Name [1] 306214 0
Servatus Ltd
Country [1] 306214 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Servatus Ltd
Address
14 Lomandra Place
Coolum Beach
Qld, 4573
Country
Australia
Secondary sponsor category [1] 306690 0
None
Name [1] 306690 0
Address [1] 306690 0
Country [1] 306690 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306425 0
Metro South Health Human Research Ethics
Ethics committee address [1] 306425 0
Ethics committee country [1] 306425 0
Australia
Date submitted for ethics approval [1] 306425 0
17/09/2020
Approval date [1] 306425 0
30/12/2020
Ethics approval number [1] 306425 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 103830 0
Prof Gerald Holtmann
Address 103830 0
Department of Gastroenterology & Hepatology,
Princess Alexandra Hospital
199 Ipswich Road,
WOOLLOONGABBA,
QLD, 4102
Country 103830 0
Australia
Phone 103830 0
+61 731767792
Fax 103830 0
Email 103830 0
g.holtmann@uq.edu.au
Contact person for public queries
Name 103831 0
Teressa Hansen
Address 103831 0
Department of Gastroenterology & Hepatology,
Princess Alexandra Hospital
199 Ipswich Road,
WOOLLOONGABBA,
QLD, 4102
Country 103831 0
Australia
Phone 103831 0
+61 7 3176 9190
Fax 103831 0
Email 103831 0
teressa.hansen@health.qld.gov.au
Contact person for scientific queries
Name 103832 0
Rebekka Williams
Address 103832 0
Servatus Ltd
14 Lomandra Place
COOLUM BEACH
QLD, 4573
Country 103832 0
Australia
Phone 103832 0
+61 7 5357 6830
Fax 103832 0
Email 103832 0
rebekka.williams@servatus.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
IPD will not be made available as the investigational treatment will be patent pending


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.