Irritable Bowel SyndromeNCT06124313
A Single Group Study to Evaluate the Effects of a Vaginal Probiotic on Vaginal and Digestive Health
A study testing Vaginal Probiotic in people with Irritable Bowel Syndrome and Vaginal Health, run by Rael at 1 site in United States.
Trial summary
This is a virtual single-group study that will last 12 weeks. Participants will take 1 capsule every day, with water. Questionnaires will be completed at baseline, 2 weeks, 4 weeks, and 12 weeks. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Irritable Bowel Syndrome, Vaginal Health
- What is being tested?
- Vaginal Probiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Sep 2023to 14 Jan 2024
- 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 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women aged 18-40
- Self-reported concerns with vaginal odor, itchiness, dryness, or discharge
- Self-reported issues associated with bacterial Vaginosis, reporting three of the following symptoms:
- Unusual vaginal discharge ( thin, grayish-white or milky discharge that has a strong, fishy odor)
- Changes in vaginal odor (i.e. An unpleasant "fishy" odor)
- Vaginal itching or irritation
Show all 16Show fewer
- Discomfort or burning sensation during urination
- Self-reported symptoms associated with irritable bowel syndrome (IBS), including three of the following symptoms:
- Abdominal pain or discomfort
- Changes in bowel habits i.e. diarrhea, constipation, or a combination of both.
- Bloating
- Gas or flatulence
- Changes in stool appearance
- Mucus in the stool
- Generally healthy - don't live with any uncontrolled chronic diseases
- Willing to avoid the use of any intra-vaginal products (such as vaginal creams, gels, or medications) as well as suppositories during the study product use
Who cannot join
- Any pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders
- Planning to undergo any procedure related to their reproductive health.
- Started any new medications or supplements that target vaginal health or IBS in the past 3 months.
- Anyone with known severe allergic reactions
- Women who are pregnant, breastfeeding, or attempting to become pregnant
- Unwilling to follow the study protocol
- Anyone with a history of vaginal, cervical, vulvar, uterine, or ovarian cancer
- Anyone who has changed or stopped taking hormonal birth control in the last 3 months
Trial locations and contacts
1 site in 1 country.
About this study
This is a virtual single-group study that will last 12 weeks. Participants will take 1 capsule every day, with water. Questionnaires will be completed at baseline, 2 weeks, 4 weeks, and 12 weeks.
- Conditions
- Irritable Bowel Syndrome, Vaginal Health
- Being tested
- Vaginal Probiotic
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal ProbioticDietary supplement
This product contains:
Probiotic Blend - 5 Strains Lactobacillus acidophilus Lactobacillus rhamnosus Lactobacillus gasseri Lactobacillus acidophilus (NCFM) Lactobacillus casei
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Participants will take one capsule of the test product every day, with water. Receives: Dietary Supplement: Vaginal Probiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in symptoms of bacterial vaginosis.
Participants will complete self-reported questionnaires reporting on incidence and severity of symptoms of bacterial vaginosis.
Measured: Baseline to Week 12
Changes in vaginal odor.
Participants will complete self-reported questionnaires reporting their perceptions of their vaginal odor. Responses will be gathered on a 5-point Likert scale, with 0= the most favorable severe and 5= the least favorable response.
Measured: Baseline to Week 12
Changes in vaginal itchiness.
Participants will complete self-reported questionnaires reporting the severity of vaginal itching. Responses will be gathered on a 5-point Likert scale, with 0= the least severe and 5= most severe response.
Measured: Baseline to Week 12
Changes in vaginal discharge.
Participants will complete self-reported questionnaires reporting their perceptions of their vaginal discharge. Responses will be gathered on a 5-point Likert scale, with 0= the most favorable severe and 5= the least favorable response.
Measured: Baseline to Week 12
Changes in vaginal dryness.
Participants will complete self-reported questionnaires reporting the severity of vaginal dryness. Responses will be gathered on a 5-point Likert scale, with 0= the least severe and 5= most severe response.
Measured: Baseline to Week 12
Secondary outcomes (2)
Changes in scores on the Gastrointestinal Symptom Rating Scale (GSRS).
The GSRS is a disease-specific instrument of 15 items combined into five symptom clusters depicting Reflux, Abdominal pain, Indigestion, Diarrhoea and Constipation. The GSRS has a seven-point graded Likert-type scale where 1 represents absence of troublesome symptoms and 7 represents very troublesome symptoms.
Measured: Baseline to Week 12
Changes in scores on the Bristol Stool Chart.
On the Bristol Stool Chart, stools are assigned a number from 1 to 7, from hardest to loosest. Normal stools are those in the middle of the chart, in the 3 to 4 range
Measured: Baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2023
- Study start14 Sep 2023
- Primary completion14 Jan 2024
- Study completion14 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rael
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06124313
- Sponsor's protocol ID
- 20337
- Status last verified
- Aug 2024
- First submitted
- 4 Nov 2023
- Last updated
- 23 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Group Study to Evaluate the Effects of a Vaginal Probiotic on Vaginal and Digestive Health
- ClinicalTrials.gov ID
- NCT06124313
- Acronym / sponsor ID
- 20337
- Conditions
- Irritable Bowel Syndrome, Vaginal Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- RaelIndustry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Study start
- 14 Sep 2023 (actual)
- Primary completion
- 14 Jan 2024 (actual)
- Study completion
- 14 Jan 2024 (actual)
- First posted
- 9 Nov 2023 (actual)
- 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.
This is a virtual single-group study that will last 12 weeks. Participants will take 1 capsule every day, with water. Questionnaires will be completed at baseline, 2 weeks, 4 weeks, and 12 weeks.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Dietary Supplement: Vaginal ProbioticParticipants will take one capsule of the test product every day, with water. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- Women aged 18-40
- Self-reported concerns with vaginal odor, itchiness, dryness, or discharge
- Self-reported issues associated with bacterial Vaginosis, reporting three of the following symptoms:
- Self-reported symptoms associated with irritable bowel syndrome (IBS), including three of the following symptoms:
- Generally healthy - don't live with any uncontrolled chronic diseases
Key exclusion criteria (8 listed)
- Any pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders
- Planning to undergo any procedure related to their reproductive health.
- Started any new medications or supplements that target vaginal health or IBS in the past 3 months.
- Anyone with known severe allergic reactions
- Women who are pregnant, breastfeeding, or attempting to become pregnant
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 |
|---|---|---|
| Vaginal ProbioticThis product contains: Probiotic Blend - 5 Strains Lactobacillus acidophilus Lactobacillus rhamnosus Lactobacillus gasseri Lactobacillus acidophilus (NCFM) Lactobacillus casei | Dietary supplement | Intervention Group |
Primary outcome
Changes in symptoms of bacterial vaginosis.
Time frame: Baseline to Week 12
Participants will complete self-reported questionnaires reporting on incidence and severity of symptoms of bacterial vaginosis.
Changes in vaginal odor.
Time frame: Baseline to Week 12
Participants will complete self-reported questionnaires reporting their perceptions of their vaginal odor. Responses will be gathered on a 5-point Likert scale, with 0= the most favorable severe and 5= the least favorable response.
Changes in vaginal itchiness.
Time frame: Baseline to Week 12
Participants will complete self-reported questionnaires reporting the severity of vaginal itching. Responses will be gathered on a 5-point Likert scale, with 0= the least severe and 5= most severe response.
Changes in vaginal discharge.
Time frame: Baseline to Week 12
Participants will complete self-reported questionnaires reporting their perceptions of their vaginal discharge. Responses will be gathered on a 5-point Likert scale, with 0= the most favorable severe and 5= the least favorable response.
Changes in vaginal dryness.
Time frame: Baseline to Week 12
Participants will complete self-reported questionnaires reporting the severity of vaginal dryness. Responses will be gathered on a 5-point Likert scale, with 0= the least severe and 5= most severe response.
2 secondary outcomes
Changes in scores on the Gastrointestinal Symptom Rating Scale (GSRS).
Time frame: Baseline to Week 12
Changes in scores on the Bristol Stool Chart.
Time frame: Baseline to Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
- Individual participant dataSharing planned: Undecided
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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 Vaginal Probiotic in people with Irritable Bowel Syndrome and Vaginal Health, run by Rael at 1 site in United States.
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 16 inclusion and 8 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: finished, as of the sponsor's last update on 23 Aug 2024. 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 United States. 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes in symptoms of bacterial vaginosis. (time frame: Baseline to Week 12). The study lists 5 primary outcomes in all. 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 23 Aug 2024.