Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04991818
Other study ID # SBB20R&33310
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2021
Est. completion date April 29, 2022

Study information

Verified date January 2023
Source Danone Asia Pacific Holdings Pte, Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Evaluating the user (pregnant women and parents of young children) experience of the OneBiome consumers value journey service offered to the 1000 days and young children consumers market


Description:

The OneBiome service aims to empower consumers with microbiome science in a friendly/consumer centric manner. The investigators wants to show that microbiome data can be used as an estimate of consumer's health and can be translated into actionable insights. The investigators aim to pilot a consumers' insight study to measure the perception/sentiments of this service in the Singapore market by recruiting study subjects from local public/private hospitals.


Recruitment information / eligibility

Status Completed
Enrollment 90
Est. completion date April 29, 2022
Est. primary completion date March 19, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 0 Months and older
Eligibility Inclusion Criteria: 1. Pregnant women who are in the third trimester, or children from birth to 5 years of age 2. Pregnant women or parents of children should have access to the internet and a smartphone or tablet to access the OneBiome mobile friendly website. 3. Pregnant women or parents of children should be able to comprehend the content in the OneBiome mobile friendly website and complete the questionnaires in English. 4. Pregnant women and parents of children should stay in Singapore and remain contactable should they decide to do two microbiome assessments within 8 weeks Exclusion Criteria: 1. Children born prematurely 2. Incapability of the pregnant women or parents of children to access OneBiome mobile friendly website and complete the questionnaires in English. 3. Any other family member is enrolled in the study 4. Incapability of the pregnant women or parents of children to comply with study protocol or Investigator's uncertainty about the willingness or ability of the pregnant women or parents of children to comply with the protocol requirements

Study Design


Related Conditions & MeSH terms


Intervention

Other:
OneBiome microbiome profiling service
participants will be asked to complete the user experience of the OneBiome service

Locations

Country Name City State
Singapore KK Women's and Children's Hospital Singapore
Singapore Mount Elizabeth Medical Centre Singapore

Sponsors (4)

Lead Sponsor Collaborator
Danone Asia Pacific Holdings Pte, Ltd. Chiang Children's Allergy and Asthma Clinic, KK Women's and Children's Hospital, The Child and Allergic Clinic

Country where clinical trial is conducted

Singapore, 

Outcome

Type Measure Description Time frame Safety issue
Other Microbiome composition of the participants Microbiome composition in the stool sample of the subject which will be included in the microbiome analysis report to be shared with subject/ parent's subject. Approximately 8 weeks
Other Association between microbiome composition and known factors that influence the microbiome Association between microbiome composition and known factors that influence the microbiome in early life including mode of delivery, antibiotic prophylaxis, infant feeding patterns and diet. Approximately 8 weeks
Other Food frequency questionnaire translation into food groups FFQ data at the beginning and at the end of the study based on translation of FFQ into food groups according to the healthy plate guideline from the Health Promotion Board. Approximately 8 weeks
Other Association between gut health parameters, stool images, microbiome composition and dietary patterns Association between gut health parameters (symptoms, stool consistency, frequency and color, gastrointestinal infection, antibiotic intake) and stool images from participants, and microbiome composition and dietary patterns Approximately 8 weeks
Primary Overall user experience of the OneBiome microbiome profiling service Pregnant women and parents of young children reported overall user experience of the OneBiome microbiome profiling service, i.e. average rating of the four following UX surveys1) overall experience of kit discovery (from unboxing to shipment); 2) ease of use of the stool collection kit; 3) overall user experience of the OneBiome web platform; 4) overall user experience of reading and understanding the microbiome analysis report. Approximately 8 weeks
Secondary User experience of different "steps/ phases" of the OneBiome consumers value journey service Pregnant women and parents of young children reported user experience of different "steps/ phases" of the OneBiome consumers value journey service, including 'kit discovery, 'kit usage', 'web platform', 'evaluation of report', 'evaluation of service' and ''evaluation of consumer's motivation and consumption behaviour habits' Approximately 8 weeks
Secondary Healthcare professional (HCP) reported overall experience of the OneBiome consumers value journey service HCP reported overall user experience of the OneBiome microbiome profiling service Approximately 8 weeks
Secondary HCP reported usefulness of microbiome data HCP reported usefulness of microbiome data for their general practice based on user experience interaction between HCP and pregnant women and parents of young children Approximately 8 weeks
See also
  Status Clinical Trial Phase
Recruiting NCT05414994 - Assessment of the Ocular Microbiome in Health and Disease
Completed NCT04769882 - Er:YAG Laser Effects on Microbial Population in Conservative Dentistry N/A
Completed NCT04766528 - Effect of Diet on the Microbiota / Endoccanabinoidome Axis in Response to Physical Activity N/A
Completed NCT03720314 - Microbiota Profiling in IBS
Completed NCT04122612 - Shaping Microbiome in the First 1,000 Days of Life
Not yet recruiting NCT05405634 - Microbiota in Chronic Anal Fissure and Its Association With Prognosis
Not yet recruiting NCT04895774 - Ex Vivo Study of the Mechanism of Action of Active Ingredients on the Intestinal Microbiota
Recruiting NCT05992688 - The Sweet Kids Study (Stevia on Weight and Energy Effect Over Time) N/A
Recruiting NCT05502380 - Broad-spectrum Antibiotic Prophylaxis in Tumor and Infected Orthopedic Surgery Phase 3
Completed NCT05175833 - Oral Probiotics and Secondary Bacterial Pneumonia in Severe COVID-19 Phase 2
Recruiting NCT04836910 - Microbiome and Polycystic Ovaries
Recruiting NCT05603650 - Effects of Mouthrinses on the Microbiome of the Oral Cavity and GI Tract N/A
Completed NCT05575050 - Impact of Teeth Brushing in Ventilated COVID-19 Patients. N/A
Completed NCT04374955 - The Effect of Probiotic Added to Maternal Diet on Infantile Colic and Intestinal Microbiota Content N/A
Recruiting NCT04140747 - Transfer of Strictly Anaerobe Microbes From Mother to Child
Recruiting NCT04111471 - The Use of A Prebiotic to Promote a Healthy Gut Microbiome in Pediatric Stem Cell Transplant Recipients N/A
Suspended NCT03220282 - The Milk, Growth and Microbiota Study N/A
Completed NCT03422562 - Probiotics and Intestinal Microbiome in Preterm Infants Phase 3
Recruiting NCT05695196 - Feasibility and Safety Study of Parent-to-Child Nasal Microbiota Transplant Phase 1
Completed NCT04223375 - Effect of Nutrition Training on Mothers' Nutrition Pattern, Breast Milk and Newborn Intestinal Microbiota N/A