Effect of silk extract fermented with lactic acid bacteria on bowel movement -a randomized, double-blind, placebo-controlled clinical trial-

Effect of silk extract fermented with lactic acid bacteria on bowel movement -a randomized, double-blind, placebo-controlled clinical trial- - Effect of silk extract fermented with lactic acid bacteria on bowel movement -a randomized, double-blind, placebo-controlled clinical trial-

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000047859

Enrollment

Registered

2022-05-25

Start date

2022-05-25

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Interventions

Intake of fermented (by lactococcus lactis BM32-1) silk extract drink (100 mL/day) for 12 weeks. Intake of placebo drink (without silk extract and lactic acid bacteria) (100 mL/day) for 12 weeks.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Healthy male and female with defecation frequency <=4 times/week

Exclusion criteria

Exclusion criteria: 1) Allergy to silk, apple, and milk 2) Taking large volume of silk proteins habitually 3) Taking medicines for chronic disease 4) Predicted to be sick after screening 5) In pregnancy or nursing a child 6) Taking drugs that may affect the defecation frequency and intestinal microbiota 7) Participation in any clinical trial within 90 days of the commencement of the trial

Design outcomes

Primary

Measure	Time frame
Changes in defecation frequency after 12-week intake period	—

Secondary

Measure	Time frame
Changes in following items after 12-week intake period: Bristol stool form score, fecal microbiota, skin moisture, blood total IgE, body mass index, body fat percentage, blood glucose, serum AST, ALT and gamma-GTP	—

Countries

Japan

Contacts

Public ContactMasafumi Noda

Graduate School of Biomedical and Health Sciences Hiroshima University Probiotic Science for Preventive Medicine

bel@hiroshima-u.ac.jp082-257-5288

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026