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Preliminary clinical study for optimizing human intestinal preparation protocols to assess intestinal mucosal secretory IgA antibody titers.

Preliminary clinical study for optimizing human intestinal preparation protocols to assess intestinal mucosal secretory IgA antibody titers in evaluation of an orally available rice-form cholera vaccine.

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1031240006
Enrollment
2
Registered
2024-04-03
Start date
2024-03-06
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 subjects

Interventions

Sponsors

Taida Takashi
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1) Subjects who have not undergone upper or lower gastrointestinal surgery. 2) Male subjects who are at least 20 years old and less than 75 years old at the time of consent. 3) Subjects who have been fully informed of the study and who have given their consent in writing of their own free will with full understanding.

Exclusion criteria

Exclusion criteria: 1) Subjects who have received other laxatives within 1 week prior to the start of laxative administration 2) Subjects who are at risk of shock, anaphylaxis after receiving laxatives. 3) Subjects with suspected intestinal obstruction or severe constipation. 4) Subjects with diarrhea or bloody stool. 5) Other subjects who are judged by the investigator or subinvestigator to be unsuitable for the safe conduct of this study.

Design outcomes

Primary

MeasureTime frame
IgA/IgG antibody levels in intestinal lavage fluid and collections at the time of colonoscopy

Secondary

MeasureTime frame
CTB-specific IgA and IgG antibody levels in the samples. Total protein level in the samples. Physical properties analysis of multimeric IgA in the samples.

Contacts

Public ContactTakashi Taida

Chiba University Hospital

taida@chiba-u.jp+81-43-222-7171

Outcome results

None listed

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