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

JRCT ID: jRCT1031240006

Registered date:03/04/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Healthy subjects
• Date of first enrollment: 06/03/2024
• Target sample size: 2
• Study type: Interventional
• Intervention(s): Laxative administration

Outcome(s)

• Primary Outcome: IgA/IgG antibody levels in intestinal lavage fluid and collections at the time of colonoscopy

Secondary Outcome

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.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 75age old
• Gender: Male

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Kato Naoya
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development