Gastrointestinal ToxicityProRadNCT02351089
Probiotics in Radiation-treated Gynecologic Cancer
A study testing Capsules probiotic powder and corn starch in people with Gastrointestinal Toxicity and Gynecologic Cancer, run by Probi AB at 1 site in Sweden.
Trial summary
The aim of the current Project is to study the efficacy of a probiotic Product in reducing the symptoms of gastrointestinal toxicity linked to the irradiation of gynecologic cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gastrointestinal Toxicity, Gynecologic Cancer
- What is being tested?
- Capsules probiotic powder and corn starch
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 97 participants
- Where
- 1 siteSweden
- Study dates
- Feb 2015to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women diagnosed with cancer in the small pelvis and waiting to receive radiotherapy either as a primary or as a secondary treatment following surgery. Chemotherapy may or may not be part of the treatment regimen.
- Age, older than 18 years old.
- Agreement for participation in the study by signed written informed consent.
Who cannot join
- Previously treated with irradiation of the pelvic area.
- Reluctance to refrain from using other probiotic products during the participation in the study.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the current Project is to study the efficacy of a probiotic Product in reducing the symptoms of gastrointestinal toxicity linked to the irradiation of gynecologic cancer.
- Conditions
- Gastrointestinal Toxicity, Gynecologic Cancer
- Being tested
- Capsules placebo, Capsules probiotic powder and corn starch
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capsules placeboDietary supplement
Capsules
Capsules probiotic powder and corn starchDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | capsules containing corn starch Receives: Dietary Supplement: Capsules placebo |
| Probiotic low dose | Active comparator | capsules containing probiotic powder and corn starch Receives: Dietary Supplement: Capsules probiotic powder and corn starch |
| Probiotic high dose | Active comparator | capsules containing probiotic powder and corn starch Receives: Dietary Supplement: Capsules probiotic powder and corn starch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in incidence of loose/watery stools
Measured: Baseline and 10 weeks later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2015 (estimated)
- Study startFeb 2015
- Primary completionDec 2018
- Study completionDec 2019
Why it stopped: Slow recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal ToxicityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Probi AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02351089
- Sponsor's protocol ID
- ProRad
- Acronym
- ProRad
- Status last verified
- Mar 2020
- First submitted
- 20 Jan 2015
- Last updated
- 5 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probiotics in Radiation-treated Gynecologic Cancer
- ClinicalTrials.gov ID
- NCT02351089
- Acronym / sponsor ID
- ProRad / ProRad
- Conditions
- Gastrointestinal Toxicity, Gynecologic Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow recruitment
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Probi ABIndustry (pharma, biotech, devices)
- Study start
- Feb 2015
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 30 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the current Project is to study the efficacy of a probiotic Product in reducing the symptoms of gastrointestinal toxicity linked to the irradiation of gynecologic cancer.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Capsules placebocapsules containing corn starch |
| Probiotic low dose | Active comparator | Dietary Supplement: Capsules probiotic powder and corn starchcapsules containing probiotic powder and corn starch |
| Probiotic high dose | Active comparator | Dietary Supplement: Capsules probiotic powder and corn starchcapsules containing probiotic powder and corn starch |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women diagnosed with cancer in the small pelvis and waiting to receive radiotherapy either as a primary or as a secondary treatment following surgery. Chemotherapy may or may not be part of the treatment regimen.
- Age, older than 18 years old.
- Agreement for participation in the study by signed written informed consent.
Key exclusion criteria (2 listed)
- Previously treated with irradiation of the pelvic area.
- Reluctance to refrain from using other probiotic products during the participation in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Capsules placeboCapsules | Dietary supplement | Placebo |
| Capsules probiotic powder and corn starch | Dietary supplement | Probiotic high dose, Probiotic low dose |
Primary outcome
Change in incidence of loose/watery stools
Time frame: Baseline and 10 weeks later
Results and safety
The study was stopped early (reason given: Slow recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Capsules probiotic powder and corn starch in people with Gastrointestinal Toxicity and Gynecologic Cancer, run by Probi AB at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Slow recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in incidence of loose/watery stools (time frame: Baseline and 10 weeks later). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2020.