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Effect of Maolactin on Gastrointestinal Tract (GIT) Health

NCT06104917 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 91

Last updated 2025-08-26

No results posted yet for this study

Summary

This is a randomized, double-blind, placebo-controlled, 3 arm parallel group study of 12 weeks duration, with a 4-week run-in period as the control phase and an 8-week intervention period, to investigate the effectiveness of the treatment on upper GI disturbance.

Conditions

  • Gastrointestinal Dysfunction

Interventions

DRUG

High Dose Maolactin

Once daily dose of 2 capsules (2 capsules containing 250mg active proteins per capsule; equivalent to 500mg active proteins per day)

DRUG

Low Dose Maolactin

Once daily dose of 2 capsules (1 capsule containing 250mg active proteins per capsule and 1 capsule containing maltodextrin only; equivalent to 250mg active proteins per day)

DRUG

Maltodextrin

Once daily dose of 2 capsules

Sponsors & Collaborators

  • Maolac

    collaborator UNKNOWN

  • RDC Clinical Pty Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-21
Primary Completion
2025-07-23
Completion
2025-07-23

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06104917 on ClinicalTrials.gov