Quality of LifeNCT03150927
Clinical Study of Novel Probiotic Microbial Composite™ to Treat Undernourished Young Children
A study testing Probiotic Microbial Composite in people with Quality of Life and Malnutrition, run by Biowish Technologies, Inc. at 1 site in India.
Trial summary
This study is to determine if a novel bio-fermented Microbiotic Composite™ can improve the digestive health and subsequent growth and quality of life parameters in a selected group of children in a district in India. Read more about this study
- Who is it for?
- Ages 3 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Quality of Life, Malnutrition, Growth Arrest
- What is being tested?
- Probiotic Microbial Composite
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 1 siteIndia
- Study dates
- Sep 2017to Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Inpatient setting: Children with age of 3 years to 12 years with acute diarrhea
- Outpatient setting: healthy children aged 3 years to 12 years
Who cannot join
- Subjects taking any kind of prescription medication.
- Subjects taking any dietary supplements (2-week washout is permitted).
- Subjects taking any antibiotics (must have discontinued antibiotic use 12-weeks prior to beginning study). An allowance will be made to existing subjects already taking part in the study. This confounder will however have to be noted by the primary investigators.
- Individual has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk.
- Including subjects who are bed or wheelchair-bound
- Including subjects who have any physical disability which could interfere with their ability to perform the functional performance measures included in this protocol.
Trial locations and contacts
1 site in 1 country.
India1 site
Mysore Medical College and Research Institute
Mysore, Karnataka, 570 001
Mudassir A Khan, PhD, +91 821 2520512, mudkhan@gmail.com
About this study
Official title: A Clinical Study to Determine the Effects of a Novel Probiotic Microbial Composite™ on Improving Digestive Health and Key Growth Parameters in Undernourished Young Children
This study is to determine if a novel bio-fermented Microbiotic Composite™ can improve the digestive health and subsequent growth and quality of life parameters in a selected group of children in a district in India.
Read the detailed description
The Probiotic Microbial Composite™ is a multifaceted technology that encompasses three key areas, namely, prebiotics, probiotics and post-biotics. The first component, prebiotics, involve non-digestible food ingredients, typically oligosaccharides which act by beneficially affecting the host by stimulating growth, activity, or in fact both of specific intestinal bacteria.
The probiotic component refers to the augmentation or addition of bacteria to enhance and support the various beneficial bacteria that are inherent to the gastrointestinal tract. The bio-fermented Microbiotic Composite™ is a consortium of bacteria which can play a significant physiological role as a probiotic. This theory, termed the microbial consortium theory suggests that rather than a cumulative effect by the bacteria, there is in fact combinatorial affect by the use of several species.
The final component post-biotics, in general, mimic the beneficial health promoting effects of probiotics whilst avoiding the risk of taking live micro-organisms within the gastrointestinal tract, especially in populations such as infants and the elderly in whom the intestinal barriers, as well as, innate immune defenses can be impaired. The term typically encompasses a vast plethora of byproducts, know as metabolites, produced and secreted by the bacteria in response to their environment.
- Conditions
- Quality of Life, Malnutrition, Growth Arrest
- Being tested
- Probiotic Microbial Composite, Placebo
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic Microbial CompositeDietary supplement
125mg (or 250 mg) of BiOWiSH Probiotic Microbial Composite™ is to be dosed once daily. Product will be supplied in capsule form to be administered orally. Each subject will be given a 15-day supply (30 capsules) to take with them after their initial visit. Capsules will be administered every 15 days by primary investigators at follow up visits.
PlaceboDietary supplement
125mg (or 250 mg) of Placebo is to be dosed once daily. Product will be supplied in capsule form to be administered orally. Each subject will be given a 15-day supply (30 capsules) to take with them after their initial visit. Capsules will be administered every 15 days by primary investigators at follow up visits.
| Study group | Role | What they receive |
|---|---|---|
| Probiotic Microbial Composite | Experimental | Probiotic Microbial Composite is a safe, 100% natural material containing all Generally Recognized as Safe (GRAS) Probiotics, combined with FDA approved food grade excipient materials. The probiotics contained within are also all 100% natural and non-Genetically Modified Organisms (non-GMO). Receives: Dietary Supplement: Probiotic Microbial Composite |
| Placebo | Placebo comparator | Placebo is a mixture of inactive ingredients found in Probiotic Microbial Composite. These ingredients are FDA approved food grade materials, 100% natural and palatable. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute diarrhea in children ages 3 years to 12 years
Subjects will be assessed as to severity of diarrhea using a standardized measure of diarrheal severity in pediatrics
Measured: 24 weeks
Secondary outcomes (4)
Serial assessment of healthy children aged 3 years to 12 years
Subjects will be followed by serial assessment of mid-arm circumference measured in centimeters.
Measured: 2 years
Serial assessment of healthy children aged 3 years to 12 years
Subjects will be followed by serial assessment of head circumference measured in centimeters.
Measured: 2 years
Height of healthy children aged 3 years to 12 years
Subjects will be followed by serial assessment of height in centimeters
Measured: 2 years
Weight of healthy children aged 3 years to 12 years
Subjects will be followed by serial assessment of weight in kilograms
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2017
- Study startSep 2017 (estimated)
- Primary completionSep 2018 (estimated)
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (50)Papers the sponsor has linked to this study.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The Randomized Clinical Trial (RCT) will typically involve 250 subjects randomized into two arms based on age and sex. Following a positive outcome in the RCT (following 6 months), we envisage converting the study to an observational based study (case-study) based on ethical principles where the placebo arm of the study would be administered the test product. Each subject will be assessed for a total of two years.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biowish Technologies, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- University of Wollongong, Mysore Medical College and Research Institute
- Responsible party
- Sponsor
- Investigators
- Mudassir A Khan, Ph.D., Principal investigator, Department of Community Medicine/Public Health Mysore Medical College & Research InstituteAmit Kapur, MBBS, Principal investigator, Prince of Wales Hospital, Shatin, Hong KongRichard S Carpenter, PhD, Principal investigator, Biowish Technologies, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03150927
- Sponsor's protocol ID
- BWT-20150720-001
- Status last verified
- May 2017
- First submitted
- 5 Apr 2017
- Last updated
- 12 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Allen SJ, Okoko B, Martinez E, Gregorio G, Dans LF. Probiotics for treating infectious diarrhoea. Cochrane Database Syst Rev. 2004;(2):CD003048. doi: 10.1002/14651858.CD003048.pub2.
PubMed 15106189Asuzu MC. A comparative study of the commonly used nutritional assessment tools for primary health care. East Afr Med J. 1991 Nov;68(11):913-22.
PubMed 1800086Bhutta ZA, Das JK. Interventions to address maternal and childhood undernutrition: current evidence. Nestle Nutr Inst Workshop Ser. 2014;78:59-69. doi: 10.1159/000354941. Epub 2014 Jan 27.
PubMed 24504207Canani RB, Cirillo P, Terrin G, Cesarano L, Spagnuolo MI, De Vincenzo A, Albano F, Passariello A, De Marco G, Manguso F, Guarino A. Probiotics for treatment of acute diarrhoea in children: randomised clinical trial of five different preparations. BMJ. 2007 Aug 18;335(7615):340. doi: 10.1136/bmj.39272.581736.55. Epub 2007 Aug 9.
PubMed 17690340D'Souza AL, Rajkumar C, Cooke J, Bulpitt CJ. Probiotics in prevention of antibiotic associated diarrhoea: meta-analysis. BMJ. 2002 Jun 8;324(7350):1361. doi: 10.1136/bmj.324.7350.1361.
PubMed 12052801Depeint F, Tzortzis G, Vulevic J, I'anson K, Gibson GR. Prebiotic evaluation of a novel galactooligosaccharide mixture produced by the enzymatic activity of Bifidobacterium bifidum NCIMB 41171, in healthy humans: a randomized, double-blind, crossover, placebo-controlled intervention study. Am J Clin Nutr. 2008 Mar;87(3):785-91. doi: 10.1093/ajcn/87.3.785.
PubMed 18326619Fang SB, Lee HC, Hu JJ, Hou SY, Liu HL, Fang HW. Dose-dependent effect of Lactobacillus rhamnosus on quantitative reduction of faecal rotavirus shedding in children. J Trop Pediatr. 2009 Oct;55(5):297-301. doi: 10.1093/tropej/fmp001. Epub 2009 Feb 8.
PubMed 19203988Grosse SD, Roy K. Long-term economic effect of early childhood nutrition. Lancet. 2008 Feb 2;371(9610):365-6. doi: 10.1016/S0140-6736(08)60180-4. No abstract available.
PubMed 18242398Guarino A, Canani RB, Spagnuolo MI, Albano F, Di Benedetto L. Oral bacterial therapy reduces the duration of symptoms and of viral excretion in children with mild diarrhea. J Pediatr Gastroenterol Nutr. 1997 Nov;25(5):516-9. doi: 10.1097/00005176-199711000-00005.
PubMed 9360205Gueimonde M, Sakata S, Kalliomaki M, Isolauri E, Benno Y, Salminen S. Effect of maternal consumption of lactobacillus GG on transfer and establishment of fecal bifidobacterial microbiota in neonates. J Pediatr Gastroenterol Nutr. 2006 Feb;42(2):166-70. doi: 10.1097/01.mpg.0000189346.25172.fd.
PubMed 16456409Hoddinott J, Maluccio JA, Behrman JR, Flores R, Martorell R. Effect of a nutrition intervention during early childhood on economic productivity in Guatemalan adults. Lancet. 2008 Feb 2;371(9610):411-6. doi: 10.1016/S0140-6736(08)60205-6.
PubMed 18242415Hooper LV, Midtvedt T, Gordon JI. How host-microbial interactions shape the nutrient environment of the mammalian intestine. Annu Rev Nutr. 2002;22:283-307. doi: 10.1146/annurev.nutr.22.011602.092259. Epub 2002 Apr 4.
PubMed 12055347Johnston BC, Supina AL, Ospina M, Vohra S. Probiotics for the prevention of pediatric antibiotic-associated diarrhea. Cochrane Database Syst Rev. 2007 Apr 18;(2):CD004827. doi: 10.1002/14651858.CD004827.pub2.
PubMed 17443557Kalliomaki M, Salminen S, Poussa T, Isolauri E. Probiotics during the first 7 years of life: a cumulative risk reduction of eczema in a randomized, placebo-controlled trial. J Allergy Clin Immunol. 2007 Apr;119(4):1019-21. doi: 10.1016/j.jaci.2006.12.608. Epub 2007 Feb 7. No abstract available.
PubMed 17289135Kosek M, Bern C, Guerrant RL. The global burden of diarrhoeal disease, as estimated from studies published between 1992 and 2000. Bull World Health Organ. 2003;81(3):197-204. Epub 2003 May 16.
PubMed 12764516
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Determine the Effects of a Novel Probiotic Microbial Composite™ on Improving Digestive Health and Key Growth Parameters in Undernourished Young Children
- ClinicalTrials.gov ID
- NCT03150927
- Acronym / sponsor ID
- BWT-20150720-001
- Conditions
- Quality of Life, Malnutrition, Growth Arrest
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Biowish Technologies, Inc.University, hospital or other
- Collaborators
- University of Wollongong, Mysore Medical College and Research Institute
- Study start
- Sep 2017 (estimated)
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 12 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is to determine if a novel bio-fermented Microbiotic Composite™ can improve the digestive health and subsequent growth and quality of life parameters in a selected group of children in a district in India.
Detailed description
The Probiotic Microbial Composite™ is a multifaceted technology that encompasses three key areas, namely, prebiotics, probiotics and post-biotics. The first component, prebiotics, involve non-digestible food ingredients, typically oligosaccharides which act by beneficially affecting the host by stimulating growth, activity, or in fact both of specific intestinal bacteria.
The probiotic component refers to the augmentation or addition of bacteria to enhance and support the various beneficial bacteria that are inherent to the gastrointestinal tract. The bio-fermented Microbiotic Composite™ is a consortium of bacteria which can play a significant physiological role as a probiotic. This theory, termed the microbial consortium theory suggests that rather than a cumulative effect by the bacteria, there is in fact combinatorial affect by the use of several species.
The final component post-biotics, in general, mimic the beneficial health promoting effects of probiotics whilst avoiding the risk of taking live micro-organisms within the gastrointestinal tract, especially in populations such as infants and the elderly in whom the intestinal barriers, as well as, innate immune defenses can be impaired. The term typically encompasses a vast plethora of byproducts, know as metabolites, produced and secreted by the bacteria in response to their environment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- The Randomized Clinical Trial (RCT) will typically involve 250 subjects randomized into two arms based on age and sex. Following a positive outcome in the RCT (following 6 months), we envisage converting the study to an observational based study (case-study) based on ethical principles where the placebo arm of the study would be administered the test product. Each subject will be assessed for a total of two years.
| Arm | Type | Receives |
|---|---|---|
| Probiotic Microbial Composite | Experimental | Dietary Supplement: Probiotic Microbial CompositeProbiotic Microbial Composite is a safe, 100% natural material containing all Generally Recognized as Safe (GRAS) Probiotics, combined with FDA approved food grade excipient materials. The probiotics contained within are also all 100% natural and non-Genetically Modified Organisms (non-GMO). |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo is a mixture of inactive ingredients found in Probiotic Microbial Composite. These ingredients are FDA approved food grade materials, 100% natural and palatable. |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Inpatient setting: Children with age of 3 years to 12 years with acute diarrhea
- Outpatient setting: healthy children aged 3 years to 12 years
Key exclusion criteria (6 listed)
- Subjects taking any kind of prescription medication.
- Subjects taking any dietary supplements (2-week washout is permitted).
- Subjects taking any antibiotics (must have discontinued antibiotic use 12-weeks prior to beginning study). An allowance will be made to existing subjects already taking part in the study. This confounder will however have to be noted by the primary investigators.
- Individual has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probiotic Microbial Composite125mg (or 250 mg) of BiOWiSH Probiotic Microbial Composite™ is to be dosed once daily. Product will be supplied in capsule form to be administered orally. Each subject will be given a 15-day supply (30 capsules) to take with them after their initial visit. Capsules will be administered every 15 days by primary investigators at follow up visits. | Dietary supplement | Probiotic Microbial Composite |
| Placebo125mg (or 250 mg) of Placebo is to be dosed once daily. Product will be supplied in capsule form to be administered orally. Each subject will be given a 15-day supply (30 capsules) to take with them after their initial visit. Capsules will be administered every 15 days by primary investigators at follow up visits. | Dietary supplement | Placebo |
Primary outcome
Acute diarrhea in children ages 3 years to 12 years
Time frame: 24 weeks
Subjects will be assessed as to severity of diarrhea using a standardized measure of diarrheal severity in pediatrics
4 secondary outcomes
Serial assessment of healthy children aged 3 years to 12 years
Time frame: 2 years
Serial assessment of healthy children aged 3 years to 12 years
Time frame: 2 years
Height of healthy children aged 3 years to 12 years
Time frame: 2 years
Weight of healthy children aged 3 years to 12 years
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2017.
- Background: PubMed 15106189Allen SJ, Okoko B, Martinez E, Gregorio G, Dans LF. Probiotics for treating infectious diarrhoea. Cochrane Database Syst Rev. 2004;(2):CD003048. doi: 10.1002/14651858.CD003048.pub2.
- Background: PubMed 1800086Asuzu MC. A comparative study of the commonly used nutritional assessment tools for primary health care. East Afr Med J. 1991 Nov;68(11):913-22.
- Background: PubMed 24504207Bhutta ZA, Das JK. Interventions to address maternal and childhood undernutrition: current evidence. Nestle Nutr Inst Workshop Ser. 2014;78:59-69. doi: 10.1159/000354941. Epub 2014 Jan 27.
- Background: PubMed 17690340Canani RB, Cirillo P, Terrin G, Cesarano L, Spagnuolo MI, De Vincenzo A, Albano F, Passariello A, De Marco G, Manguso F, Guarino A. Probiotics for treatment of acute diarrhoea in children: randomised clinical trial of five different preparations. BMJ. 2007 Aug 18;335(7615):340. doi: 10.1136/bmj.39272.581736.55. Epub 2007 Aug 9.
- Background: PubMed 12052801D'Souza AL, Rajkumar C, Cooke J, Bulpitt CJ. Probiotics in prevention of antibiotic associated diarrhoea: meta-analysis. BMJ. 2002 Jun 8;324(7350):1361. doi: 10.1136/bmj.324.7350.1361.
- Background: PubMed 18326619Depeint F, Tzortzis G, Vulevic J, I'anson K, Gibson GR. Prebiotic evaluation of a novel galactooligosaccharide mixture produced by the enzymatic activity of Bifidobacterium bifidum NCIMB 41171, in healthy humans: a randomized, double-blind, crossover, placebo-controlled intervention study. Am J Clin Nutr. 2008 Mar;87(3):785-91. doi: 10.1093/ajcn/87.3.785.
- Background: PubMed 19203988Fang SB, Lee HC, Hu JJ, Hou SY, Liu HL, Fang HW. Dose-dependent effect of Lactobacillus rhamnosus on quantitative reduction of faecal rotavirus shedding in children. J Trop Pediatr. 2009 Oct;55(5):297-301. doi: 10.1093/tropej/fmp001. Epub 2009 Feb 8.
- Background: PubMed 18242398Grosse SD, Roy K. Long-term economic effect of early childhood nutrition. Lancet. 2008 Feb 2;371(9610):365-6. doi: 10.1016/S0140-6736(08)60180-4. No abstract available.
- Background: PubMed 9360205Guarino A, Canani RB, Spagnuolo MI, Albano F, Di Benedetto L. Oral bacterial therapy reduces the duration of symptoms and of viral excretion in children with mild diarrhea. J Pediatr Gastroenterol Nutr. 1997 Nov;25(5):516-9. doi: 10.1097/00005176-199711000-00005.
- Background: PubMed 16456409Gueimonde M, Sakata S, Kalliomaki M, Isolauri E, Benno Y, Salminen S. Effect of maternal consumption of lactobacillus GG on transfer and establishment of fecal bifidobacterial microbiota in neonates. J Pediatr Gastroenterol Nutr. 2006 Feb;42(2):166-70. doi: 10.1097/01.mpg.0000189346.25172.fd.
- Background: PubMed 18242415Hoddinott J, Maluccio JA, Behrman JR, Flores R, Martorell R. Effect of a nutrition intervention during early childhood on economic productivity in Guatemalan adults. Lancet. 2008 Feb 2;371(9610):411-6. doi: 10.1016/S0140-6736(08)60205-6.
- Background: PubMed 12055347Hooper LV, Midtvedt T, Gordon JI. How host-microbial interactions shape the nutrient environment of the mammalian intestine. Annu Rev Nutr. 2002;22:283-307. doi: 10.1146/annurev.nutr.22.011602.092259. Epub 2002 Apr 4.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mudassir A Khan, Ph.D. principal investigator
Department of Community Medicine/Public Health Mysore Medical College & Research Institute
Amit Kapur, MBBS principal investigator
Prince of Wales Hospital, Shatin, Hong Kong
Richard S Carpenter, PhD principal investigator
Biowish Technologies, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic Microbial Composite in people with Quality of Life and Malnutrition, run by Biowish Technologies, Inc. at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact JoElla Barnes (+1 312 402 1669, jbarnes@biowishtech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute diarrhea in children ages 3 years to 12 years (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03150927, which also lists 50 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2017.