The effect of compound Lactobacillus on the reproductive tract of childbearing-aged women
| ISRCTN | ISRCTN82250363 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN82250363 |
- Submission date
- 05/05/2023
- Registration date
- 10/05/2023
- Last edited
- 31/10/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
Background and study aims
The microorganisms of the reproductive tract are critical to women's reproductive health, and the vaginal microorganisms of healthy women of reproductive age are dominated by the bacteria Lactobacillus. Studies have shown that clinically confirmed or unexplained vaginal infectious diseases are associated with an imbalance in vaginal microbes. The study will evaluate the effect of compound lactic acid bacteria in regulating the symptoms and indicators of reproductive tract health, will evaluate the colonization of vaginal strains after oral administration of three strains, will analyze the change of vaginal microorganisms, and also discuss the potential mechanism of the effect of probiotic strains on the vaginal environment.
Who can participate?
Women aged 18-55 years with a vaginal pH of over 4.5
What does the study involve?
Participants will be randomly allocated to the intervention group or the control group. The intervention and control groups receive one sachet of probiotic solid drink or placebo (dummy) orally with meals daily for one menstrual cycle without interruption during menstruation. Participants are required to take stool and vaginal discharge samples before the intervention, on day 7, day 14, and 2-3 days after the end of the next menstrual period, and to complete the research questionnaire before the intervention, on day 7, day 14, day 21, and 3-5 days after the end of the next menstrual period.
What are the possible benefits and risks of participating?
The intervention may help regulate the vaginal micro-ecosystem and promote reproductive tract health. Participants in the control group may have no direct benefits. The main risk of the study is that symptoms such as bloating and diarrhea will occur briefly at the beginning of the intervention and will disappear after a short time.
Where is the study run from?
BGI Precision Nutrition (Shenzhen) Technology Co., Limited (China)
When is the study starting and how long is it expected to run for?
December 2022 to September 2024
Who is funding the study?
BGI Precision Nutrition (Shenzhen) Technology Co., Limited (China)
Who is the main contact?
Rui Zhang, zhangrui16@genomics.cn
Contact information
Principal Investigator
Floor 6
Building 11
Beishan industrial zone
Yantian Street
Shenzhen
518000
China
| Phone | +86 (0)13823223717 |
|---|---|
| zhangrui16@genomics.cn |
Study information
| Study design | Interventional double-blinded randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Home |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | The effect of compound Lactobacillus on the reproductive tract of childbearing-aged women: a prospective, randomized, double-blind controlled study |
| Study objectives | 1. Lactobacillus compound is more effective than placebo in lowering vaginal pH in sub-healthy women (p<0.05) 2. Lactobacillus compound is more effective than placebo in increasing the relative abundance of Lactobacillus in the vagina (p<0.05) 3. Lactobacillus compound is more effective than placebo in increasing the relative abundance of the three vaginal species (P<0.05) 4. Lactobacillus compound is more effective than placebo in increasing the relative abundance of Lactobacillus in the feces (P<0.05) 5. Lactobacillus compound increases the relative abundance of the three species in the feces better than placebo (P<0.05) 6. Lactobacillus compound is well tolerated and the incidence of product-related adverse events is not higher than placebo (P<0.05) |
| Ethics approval(s) | Approved 13/04/2023, The Institutional Review Board of BGI (Comprehensive Building, Beishan Industrial Zone, Yantian District, Shenzhen, Guangdong, China; +86 (0)75536307890; bgi-irb@genomics.cn), ref: BGI-IRB 23056 |
| Health condition(s) or problem(s) studied | Women with a vaginal pH greater than 4.5 |
| Intervention | Participants will be randomly allocated to the intervention group or the control group. The researcher will generate a random sequence with a random number table. The envelope method is used to carry out concealed allocation: 116 opaque envelopes are taken, the envelopes are marked with the number of the injection group, and the grouping information according to the randomisation form is indicated in the envelopes, and the envelopes are sealed. After the participants are enrolled in the group in sequence, the researchers open the envelopes one by one, determine the grouping of the patients according to the distribution plan in the envelope, and extract the corresponding products. Participants in the intervention group will receive compound Lactobacillus one sachet/day, while participants in the control group will receive a placebo one sachet/day. Participants take the sachet orally with meals daily for one menstrual cycle without interruption during menstruation. Participants are required to take stool and vaginal discharge samples before the intervention, on day 7, day 14, and 2-3 days after the end of the next menstrual period, and to complete the research questionnaire before the intervention, on day 7, day 14, day 21, and 3-5 days after the end of the next menstrual period. |
| Intervention type | Supplement |
| Primary outcome measure | Vaginal pH values are measured using a self-testing vaginal pH kit at baseline, 7, 14, 21, and 2-3 days after the next menstruation |
| Secondary outcome measures | 1. The relative abundance and increase of the three strains in virginal discharge will be measured using vaginal discharge collection kits at baseline, 7, and 2-3 days after the next menstruation 2. The abundance and increase of Lactobacillus in virginal discharge will be measured using vaginal discharge collection kits at baseline, 7, and 2-3 days after the next menstruation 3. The detected rate and abundance of the virginal particular pathogen will be measured using vaginal discharge collection kits at baseline, 7, and 2-3 days after the next menstruation 4. The increase and relative abundance of the three strains in feces will be measured using fecal collection kits at baseline, 7, and 2-3 days after the next menstruation 5. The relative abundance and increase of Lactobacillus in feces will be measured using fecal collection kits at baseline, 7, and 2-3 days after the next menstruation 6. The comparison of alpha-diversity of the fecal microbiota will be measured using fecal collection kits at baseline, 7, and 2-3 days after the next menstruation 7. The increase of the relative abundance of short-chain fatty acid producing bacteria in gut microbiota will be measured using fecal collection kits at baseline, 7, and 2-3 days after the next menstruation |
| Overall study start date | 01/12/2022 |
| Completion date | 30/09/2024 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 55 Years |
| Sex | Female |
| Target number of participants | 116-200 |
| Total final enrolment | 192 |
| Key inclusion criteria | 1. Non-menopausal women aged 18-55 years 2. Self-test vaginal pH value over 4.5 at 2 or 3 days after menstruation 3. Willing to stop consuming probiotic supplements (yoghurt excluded) within 1 week of enrollment and to stop consuming fiber supplements during the intervention 4. Sign the informed consent |
| Key exclusion criteria | 1. Menopause 2. Pregnancy, latency, and prepared pregnancy 3. Systemic antibiotic exposure 1 week before enrollment 4. Diagnosed with the systematic disease 5. History of gastrointestinal surgery or cancer 6. Diagnosed with the reproductive disease 7. Atopic, or allergy to the known ingredient of the product |
| Date of first enrolment | 01/06/2023 |
| Date of final enrolment | 01/08/2024 |
Locations
Countries of recruitment
- China
Study participating centre
Shenyan Road
Haishan Street
Yantian District
Shenzhen
518000
China
Sponsor information
Industry
Floor 6, Building 11
Beishan industrial zone
Yantian Street
Shenzhen
518000
China
| Phone | +86 (0)13246430421 |
|---|---|
| zhongyiyi@genomics.cn |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 31/10/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Published as a supplement to the results publication |
| Publication and dissemination plan | The datasets generated and/or analysed during the current study will be published as a supplement to the results publication. |
| IPD sharing plan | The researchers will upload all the biometric information to databases and provide all the clinical phenotype data of participants after the research article is published |
Editorial Notes
31/10/2024: The following changes were made to the study record:
1. Contact details updated.
2. The recruitment end date was changed from 01/10/2024 to 01/08/2024.
3. The overall study end date was changed from 31/12/2024 to 30/09/2024.
4. The intention to publish date was changed from 31/10/2024 to 31/10/2026.
5. Total final enrolment added.
09/05/2023: Trial's existence confirmed by the Institutional Review Board of BGI.
