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A physician-initiated translation of independent single-blind research for rice-based oral cholera vaccine, MucoRice-CTB in healthy volunteers

A physician-initiated translation of independent single-blind research for rice-based oral cholera vaccine, MucoRice-CTB in healthy volunteers - A physician-initiated independent translation research for MucoRice-CTB in healthy volunteers

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000009688
Enrollment
20
Registered
2013-01-22
Start date
2013-01-22
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

Cholera, Traveler&#39

Interventions

Test group(N=10) MucoRice-CTB (rice powder 750mg containing 1mg of CTB) Control group(N=10) Wild &amp
type rice (rice powder 750mg)

Sponsors

IMSUT Hospital, The Institute of Medical Science, The University of Tokyo
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: Healthy male Age between 20 to 40 Negative test for anti-CT fecal IgA No severe hepatological, renal or hematological disorder No severe heart disease No medications Able and willing to give valid written informed consent

Exclusion criteria

Exclusion criteria: Rice allergy Past history of cholera or traveler's diarrhea Severe constipation Decision of unsuitableness by principal investigator

Design outcomes

Primary

MeasureTime frame
(1)CTB-specific serum IgG/IgA and CTB-specific fecal IgA immune responses (2)Safety issue: Rice-specific serum IgE immune response

Countries

Japan

Outcome results

None listed

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