Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202401853406618 Date of Approval: 12/01/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Study of the gut microbiota modulatory potential of two popular drinks in northern Nigeria
Official scientific title Study of the gut microbiota modulatory potential of two popular drinks in northern Nigeria
Brief summary describing the background and objectives of the trial The gut microbiota is home to more than 500 philotypes or approximately 1 million bacterial genes. It provides a secondary barrier against pathogenic colonisation. It is also host to neurons hormones and secondary messengers (largest neuroendocrine organ in the body) and therefore regulates many physiological functions. In the same way a dysbiosis of the gut microbiota could result in proliferation of pathogenic strains of bacteria and impair the physiologic functions of the body, it could also be deliberately modulated to achieve beneficial effects through competitive exclusion. This has been demonstrated in many researches just as whole cereal grain have been shown to have potential health effects. The general objective of this research is to study possible oral and gut microbiota changes due to consumption of local drinks for a period of two weeks, comparing microbiota profile before, during and after consumption.
Type of trial Observational
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Digestive System,Nutritional, Metabolic, Endocrine,Oral Health
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/02/2024
Actual trial start date 01/02/2024
Anticipated date of last follow up 14/03/2024
Actual Last follow-up date 14/03/2024
Anticipated target sample size (number of participants) 36
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Non-randomised Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Kunun Aya 500ml of the drink (tiger nut drink) taken once a day Everyday for two weeks Kunun Aya is the traditional name for Tiger nuts drink popular in Northern Nigeria. It is typically consumed occassionally but as a product of fermentation has potential gut and oral microbiota enhancing properties. 12
Experimental Group Kunun zaki 500ml Everyday for 14days Kunun Zaki is the traditional name for a local drink made from fermented guinea corn, popular in Northern Nigeria. It is typically consumed occasionally but as a product of fermentation has potential gut and oral microbiota enhancing properties. 12
Control Group Water 500ml 14 days This group only serves for the purpose of control. 12 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Age between 18 and 30 years, good general health, and a signed consent form. Engaging in any of these during 2 weeks prior to the first sample collection; antibiotic use, intentional intake of probiotic or prebiotic products, presence of gastrointestinal disorders such as diarrhea, inflammatory bowel disease, or irritable bowel syndrome, pregnancy or breastfeeding, alcoholism and drug addiction. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 11 Year(s) 60 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 11/01/2021 INSTITUTE FOR ADVANCED MEDICAL RESEARCH AND TRAINING
Ethics Committee Address
Street address City Postal code Country
UCH, Ibadan IBADAN 200109 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Interventions will lead to an increase in oral and gut microbiome population and diversity as well as decrease the chances of secondary succession by pathogens By comparing microbial diversity across all three stages of sample collection
Secondary Outcome The research could reveal significant inter-relationship between immunity, health, gut and oral microbiota, and fermented drinks. By comparing samples collected across all stages of sample collection
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kaduna State Randomly selected across the State Kaduna 812103 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
AUDU HARUNA JIMOH No 48 Imo Street, Trdemore Estate, Lugbe FCT 90001 Nigeria
Dr Funmilola Ayeni Environmental and Occupational Health Innovation Center 2719 E 10th Street Bloomington, Indiana 47408 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor AUDU HARUNA JIMOH No 48 Imo Street Trademore Estate, Lugbe Abuja 900001 Nigeria SELF
Secondary Sponsor Dr Funmilola Ayeni Environmental and Occupational Health Innovation Center 2719 E 10th Street Bloomington, Indiana 47408 United States of America PhD Supervisor
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Public Enquiries Haruna Jimoh Audu harun1789@yahoo.com +2347052885144 No. 48 Imo Street, Trademore Estate Lugbe
City Postal code Country Position/Affiliation
Abuja 900001 Nigeria Student of University of Ibadan
Role Name Email Phone Street address
Scientific Enquiries Haruna Jimoh Audu harun1789@yahoo.com 2347067767564 48, Imo Street, Trademore estate, Lugbe
City Postal code Country Position/Affiliation
Abuja 900001 Nigeria Student of the University of Ibadan
Role Name Email Phone Street address
Principal Investigator Haruna Jimoh Audu harun1789@yahoo.com 2347067767564 48, Imo Street, Trademore Estate, Lugbe Abuja
City Postal code Country Position/Affiliation
Abuja 900001 Nigeria Student
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data obtained through this study may be provided to qualified researchers with academic interest in gut microbiota. Data or samples shared will be coded, with no Protected Health Information (PHI) included. Approval of the request and execution of all applicable agreements are prerequisites to the sharing of data with the requesting party. Informed Consent Form,Study Protocol Requests for IPDs can be made 1 year after publication of findings.. Access to IPD will be controlled. It will be granted based on qualification of the researcher and relevance of the research to protect the confidentiality of data as best as we could.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information