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Effect of product containing Euglena gracilis against constipation. A randomized, double-blind, placebo-controlled, crossover-group trial.

Effect of product containing Euglena gracilis against constipation. A randomized, double-blind, placebo-controlled, crossover-group trial. - Effect of product containing Euglena gracilis against constipation.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000024130
Enrollment
50
Registered
2016-09-25
Start date
2016-09-25
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

people tend to be constipated

Interventions

A glass of powder drink containing Euglena gracilis per day for 2 weeks. A glass of placebo powder drink (not containing Euglena gracilis) per day for 2 weeks.

Sponsors

KSO Corporation
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Who meet the following conditions will be required. Whose defecation frequency is no fewer than 3, nor more than 5, and meal times are three a day usually. (Who gave the informed consents in writing after receiving enough explanation of the purpose and detail of the study, understanding the study well, and deciding to attend the study with their own will.)

Exclusion criteria

Exclusion criteria: Who meet any of the following conditions will be excluded. 1,Who regularly use intestinal drug and laxatives(including strong laxatives). 2,Who use medicine such as antibiotics that affect digestion and absorption. 3,Who can not stop intake the health food to relieve constipation (including Food for Specified Health Uses (FOSHU)) during the screening period. 4,Who can not stop intake food containing viable bacteria such as Lactic acid bacteria, Bifidobacteria, Natto bacteria and/or enhanced with oligosaccharide, dietary fiber and/or the health food to relieve constipation (including Food for Specified Health Uses (FOSHU)) and/or containing a large amount of sugar alcohol during the screening period. 5, Who habitually consume higher amount of alchole (more than 360mL in terms of Japanese Sake per day). 6, Who can not stop intake food containing Euglena gracilis. 7, Who has chronic malady of digestive organ authorities. 8,Who have allergic to food. 9, Who has a medical history of diseases or surgery affecting digestion, absorption and bowel movement (except for appendicectomy). 10,Who have serious diseases requiring an urgent treatment, or who accept severe complication. 11, Who is pregnant or willing to be pregnant or breast-feeding during this study. 12, Who are participated in another clinical trial that intake/apply any of food, drug, and cosmetics, or willing to be that. 13,Who are judged unsuitable for this study by test responsibility doctor.

Design outcomes

Primary

MeasureTime frame
Defecation frequency and days of defecation frequency and amount of defecation will be measured. The changes will be compared with placebo-controlled groups.

Secondary

MeasureTime frame
Bristol Stool Form Scale, stool color and smell, feeling after defecation will be measured. The changes will be compared with placebo-controlled groups.

Countries

Japan

Contacts

Public ContactMika Komori

KSO Corporation Sales department

yoshi@kso.co.jp03-3452-7733

Outcome results

None listed

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