Effect of Biotra ® on gut health
| ISRCTN | ISRCTN69551216 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN69551216 |
| Sponsor | Innovation Labo Sciences Co., Ltd |
| Funder | Innovation Labo Sciences Co., Ltd |
- Submission date
- 02/02/2026
- Registration date
- 10/02/2026
- Last edited
- 10/02/2026
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English summary of protocol
Background and study aims
Constipation and poor bowel function are common gut health problems that can affect quality of life. Biotra® is a dietary supplement combining probiotics and fermented seaweed polyphenols, designed to improve gut microbiota activity and digestive regularity. This study aimed to evaluate whether Biotra® improves bowel habits and inflammation compared with placebo.
Who can participate?
Adults aged 21–65 years with symptoms of functional constipation meeting Rome III criteria, with BMI <35 kg/m².
What does the study involve?
Participants were randomly assigned to receive either Biotra® or placebo for 4 weeks. They took capsules daily (two at night, one in the morning). Bowel movement frequency and stool consistency were recorded, and biological samples were collected to assess inflammation and gut microbiota-related markers.
What are the possible benefits and risks of participating?
Possible benefits include improved bowel regularity, stool consistency, and reduced inflammatory markers. Risks were minimal, with adverse events monitored throughout the study period. Serious adverse events were to be reported within 24 hours.
Where is the study run from?
Medica Tokyo Laboratories (Japan)
When is the study starting and how long is it expected to run for?
The supplementation period lasted 4 weeks, with total participant involvement approximately 6 weeks including screening and follow-up.
Who is funding the study?
Innovation Labo, which provided and blinded the investigational product Biotra®
Who is the main contact?
Dr Yuki Ikeda, development@innovationlabo.com
Contact information
Scientific
Shintomi HJ bldg 5F
1-12-7 Shintomi
Tokyo
104-0041
Japan
 ORCID ID |
0000-0001-6067-4574 |
|---|---|
| Phone | +81 (0)335525335 |
| development@innovationlabo.com |
Principal investigator
14-5 Kusunokichō, Nishi-ku
Yokohama-shi, Kanagawa-ken
Yokohama
220-0003
Japan
| Phone | +81 (0)335525335 |
|---|---|
| coordinate@medica-labs.jp |
Public
Shintomi HJ bldg 5F
1-12-7 Shintomi
Tokyo
104-0041
Japan
| Phone | +81 (0)335525335 |
|---|---|
| development@innovationlabo.com |
Study information
| Primary study design | Interventional | |
|---|---|---|
| Allocation | Randomized controlled trial | |
| Masking | Blinded (masking used) | |
| Control | Placebo | |
| Assignment | Parallel | |
| Purpose | Treatment | |
| Scientific title | A prospective, randomized, double-blind, two-arm, parallel-group, placebo-controlled clinical trial to evaluate the efficacy of Biotra® supplementation on gut health parameters, including bowel movement frequency and stool consistency | |
| Study acronym | IL/NG 21-1228 | |
| Study objectives | The primary objective of this trial is to evaluate the effects of Biotra® supplementation on gut health parameters in adults with functional constipation, compared with placebo. Secondary objectives include assessing changes in fecal inflammatory markers, short-chain fatty acid (SCFA) levels, gut microbiota composition, and safety outcomes. | |
| Ethics approval(s) |
Approved 12/11/2021, Japanese Society of Anti-Aging Nutrition (Ginza, Chuo-ku, Tokyo, 104-0061, Japan; +81 (0)3 3552 5277; coordinator@jaan.jp), ref: JAAN/GH 21-125 | |
| Health condition(s) or problem(s) studied | Gut health | |
| Intervention | Participants were randomized 1:1 to receive either: 1. Biotra® supplementation (active treatment) OR 2. Placebo (control group) Both were administered orally daily (two at night, one in the morning) for 4 weeks in a double-blind parallel-group design. Block randomization was used to allocate participants to each group. | |
| Intervention type | Supplement | |
| Primary outcome measure(s) |
| |
| Key secondary outcome measure(s) |
| |
| Completion date | 28/02/2022 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 21 Years |
| Upper age limit | 65 Years |
| Sex | All |
| Target sample size at registration | 46 |
| Total final enrolment | 42 |
| Key inclusion criteria | 1. Healthy adult men or women aged 21 to 65 years (inclusive) 2. Individuals with general symptoms of constipation who met the ROME III criteria for functional constipation 3. Body Mass Index (BMI) less than 35 kg/m² 4. Female participants of child-bearing potential were required to: Use an approved method of contraception, and have a negative pregnancy test at screening 5. Female participants of non-childbearing potential had to be amenorrheic for at least 1 year or have undergone hysterectomy and/or bilateral oophorectomy 6. Ability and willingness to provide written informed consent 7. Willingness to comply with all trial procedures and study visits 8. Ability to understand the potential risks and benefits of participation 9. Availability for the full study duration (approximately 6 weeks including follow-up) |
| Key exclusion criteria | 1. Constipation due to organic or neurological lesions 2. History of pathological bowel diseases, including inflammatory bowel disease (IBD) or colon cancer 3. Abnormal liver or renal function 4. Use of any prebiotic, probiotic, or laxative supplements within 4 weeks prior to study start 5. Use of antibiotics, anti-inflammatory, or immunosuppressive drugs within the past 4 weeks 6. Known allergy to soy milk or other ingredients of the test product 7. History of alcoholism or drug abuse 8. Pregnant or lactating women 9. History of anxiety, depression, or recent intake of psychotropic drugs 10. Any other medical or personal condition that, in the investigator’s opinion, could jeopardize the study outcomes |
| Date of first enrolment | 10/01/2022 |
| Date of final enrolment | 31/01/2022 |
Locations
Countries of recruitment
- Japan
Study participating centres
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan |
Editorial Notes
03/02/2026: Study's existence confirmed by the Japanese Society of Anti-Aging Nutrition.
