ObesityPhase 4NCT04642482
Synbiotic Therapy on Intestinal Microbiota and Insulin Resistance in Obesity
A Phase 4 study testing Synbiotic (Rillus) in people with Obesity and Insulin Resistance, run by Hasanuddin University at 1 site in Indonesia.
Trial summary
Background : There is a plausible relationship between microbial gut and insulin resistance. Intervention to prevent insulin resistance by modifying the microbial gut has been proposed but limited studies demonstrates the expected impact. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity, Insulin Resistance
- What is being tested?
- Synbiotic (Rillus)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteIndonesia
- Study dates
- 24 Sep 2019to 1 Sep 2020
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age above 18 years old
- Not receive antibiotic prescription within the last 6 months
Who cannot join
- Taking medication that alters the blood sugar
- Taking probiotic or synbiotic product (such as yogurt)
- Participant who do not take the synbiotic intervention for more than 3 days consecutively
- incomplete follow up examination results
- Develop adverse effect
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Faculty of Medicine, Muhammadiyah University
Makassar, South Sulawesi, 90221
About this study
Official title: The Effect of Synbiotic on Intestinal Microbiota and HOMA-IR (Homeostatic Model Assessment of Insulin Resistance) on Obesity
Background :
There is a plausible relationship between microbial gut and insulin resistance. Intervention to prevent insulin resistance by modifying the microbial gut has been proposed but limited studies demonstrates the expected impact. One of the possible way to manipulate the microbial gut is the administration of synbiotic (prebiotic and probiotic).
Read more
Objective :
This study aim to address the impact of synbiotic administration to the microbial gut and insulin resistance.
Brief Methodology :
A Quasi Experimental study with multiple arms is conducted to healthy participants. All subjects will undergo a microbial gut taxonomic analysis using faecal sample and blood examination to determine the insulin resistance status (using Homeostatic Model Assessment for Insulin Resistance/HOMA-IR approach). Synbiotic will be given to intervention arm and active comparator will use maltodextrin. Repeated measurement will be conducted after 8 weeks and 12 weeks from the day of administration.
Hypothesis : A superiority trial hypothesis is applied, assuming that the synbiotic group will demonstrates higher variety of microbial gut and lower HOMA-IR level
Read the detailed description
Study Location :
This study will recruit the healthy participants from the university
Target Population:
Healthy Participants
General Study Design :
Quasi Experimental study with a comparator
Sample Size calculation :
Difference between two means of HOMA IR from pilot data (7) and standard deviation 2.9, with 5% Type I error, and 80% Power yielded a total of 16 participants for two arms
Management of Sample:
- Faecal Sample handling
- Patient should undergo 8 hours of fasting prior to faecal examination
- DNA Extraction
- Lysate preparation and centrifuge faecal sample
- Mixing lysate with sample
- Column wash
- DNA elution
- DNA storing
- DNA sequencing and analysis
- taxonomical analysis
- Fasting blood glucose
- Patient should undergo 8 hours of fasting prior to Fasting blood glucose
- Blood is taken from cubital vein
- Spectrometry is conducted based on the NADPH formation from the equation below D-glucose+ATP -----> Glucose-6-phospate+ADP Glucose-6-phospate+NAD ---- G-6-PDH ---> D-Gluconate-6 phospate+NADH+H
- Insulin level
- Centrifuge blood to obtain the serum
- The monoclonal anti-insulin antibody is given to the serum
- detection is based on the anti-insulin antibody and insulin complex formation
- Homeostatic Model Assessment for Insulin Resistance/ HOMA-IR value is calculated from glucose level multiply by insulin level and divided by 405.
Protection for adverse event
- All subjects are given the consent regarding the potential harm of synbiotic administration
- All subjects will follow the protocol of reporting the any adverse event (most likely, severe constipation)
- All subjects will be treated accordingly and hospitalisation if needed.
Statistical Analysis
- General Analysis : Intention To Treat (ITT)
- Propensity Score Matching will be conducted prior to intervention
- A repeated measure ANOVA will be performed, whereas Generalized Linear Mixed Model treating the intervention as dummy variable will be performed if ANOVA assumptions can not be fulfilled.
- Conditions
- Obesity, Insulin Resistance
- Being tested
- Synbiotic (Rillus), Placebo
- Keywords
- Intestinal Microbiota, Probiotic, Insulin Resistance, Obesity
- Medical subject headings
- Obesity, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Synbiotic (Rillus)Dietary supplement
Also called Rillus
Participants in this group will be given a fine powder of synbiotic formula and should be taken orally without diluted with water.
PlaceboDrug
Also called Maltodextrin
Participants in this group will be given a fine powder of maltodextrin formula and should be taken orally without diluted with water.
| Study group | Role | What they receive |
|---|---|---|
| Synbiotic | Experimental | A fine powder to be taken orally consists of
Viable cell 1,0 x 10^9 Colony Forming Unit of :
* Lactobacillus plantarum 8,55 mg
* Streptococcus thermophilus 8,55 mg
* Bifidobacterium bifidum 2,55 mg
* Fructooligosaccharide 480 mg
* Additional components : isomalt, xylitol Receives: Dietary Supplement: Synbiotic (Rillus) |
| Placebo | Active comparator | A powder of 5 gram maltodextrin is given as active comparator, taken orally. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
a value representing the insulin resistance yielded by multiplying the blood glucose value and insulin value, then divided by 405 (considering the unit of values are in mg/dL not mmol)
Measured: Changes of HOMA IR value from baseline to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2020
- Study start24 Sep 2019
- Primary completion26 Dec 2019
- Study completion1 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- A multiple-arm study involves three different groups receiving synbiotic (probiotic + prebiotic) and placebo. Observation of intestinal microbiota and insulin resistance is observed in repeated measurement
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasanuddin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bumi Herman, Hasanuddin University
- Investigators
- Nasrum Massi, Prof., Principal investigator, Hasanuddin UniversityAndi Anggeraini, Principal investigator, Hasanuddin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04642482
- Sponsor's protocol ID
- 0711201127
- Status last verified
- Nov 2020
- First submitted
- 17 Nov 2020
- Last updated
- 24 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Andreasen AS, Larsen N, Pedersen-Skovsgaard T, Berg RM, Moller K, Svendsen KD, Jakobsen M, Pedersen BK. Effects of Lactobacillus acidophilus NCFM on insulin sensitivity and the systemic inflammatory response in human subjects. Br J Nutr. 2010 Dec;104(12):1831-8. doi: 10.1017/S0007114510002874. Epub 2010 Sep 6.
PubMed 20815975Hagerty SL, Hutchison KE, Lowry CA, Bryan AD. An empirically derived method for measuring human gut microbiome alpha diversity: Demonstrated utility in predicting health-related outcomes among a human clinical sample. PLoS One. 2020 Mar 2;15(3):e0229204. doi: 10.1371/journal.pone.0229204. eCollection 2020.
PubMed 32119675Brahe LK, Astrup A, Larsen LH. Is butyrate the link between diet, intestinal microbiota and obesity-related metabolic diseases? Obes Rev. 2013 Dec;14(12):950-9. doi: 10.1111/obr.12068. Epub 2013 Aug 16.
PubMed 23947604Bermudez-Brito M, Plaza-Diaz J, Munoz-Quezada S, Gomez-Llorente C, Gil A. Probiotic mechanisms of action. Ann Nutr Metab. 2012;61(2):160-74. doi: 10.1159/000342079. Epub 2012 Oct 2.
PubMed 23037511Cani PD, Neyrinck AM, Fava F, Knauf C, Burcelin RG, Tuohy KM, Gibson GR, Delzenne NM. Selective increases of bifidobacteria in gut microflora improve high-fat-diet-induced diabetes in mice through a mechanism associated with endotoxaemia. Diabetologia. 2007 Nov;50(11):2374-83. doi: 10.1007/s00125-007-0791-0. Epub 2007 Sep 6.
PubMed 17823788Cani PD, Delzenne NM. The role of the gut microbiota in energy metabolism and metabolic disease. Curr Pharm Des. 2009;15(13):1546-58. doi: 10.2174/138161209788168164.
PubMed 19442172Chakraborti CK. New-found link between microbiota and obesity. World J Gastrointest Pathophysiol. 2015 Nov 15;6(4):110-9. doi: 10.4291/wjgp.v6.i4.110.
PubMed 26600968Le Chatelier E, Nielsen T, Qin J, Prifti E, Hildebrand F, Falony G, Almeida M, Arumugam M, Batto JM, Kennedy S, Leonard P, Li J, Burgdorf K, Grarup N, Jorgensen T, Brandslund I, Nielsen HB, Juncker AS, Bertalan M, Levenez F, Pons N, Rasmussen S, Sunagawa S, Tap J, Tims S, Zoetendal EG, Brunak S, Clement K, Dore J, Kleerebezem M, Kristiansen K, Renault P, Sicheritz-Ponten T, de Vos WM, Zucker JD, Raes J, Hansen T; MetaHIT consortium; Bork P, Wang J, Ehrlich SD, Pedersen O. Richness of human gut microbiome correlates with metabolic markers. Nature. 2013 Aug 29;500(7464):541-6. doi: 10.1038/nature12506.
PubMed 23985870Delzenne NM, Neyrinck AM, Cani PD. Gut microbiota and metabolic disorders: How prebiotic can work? Br J Nutr. 2013 Jan;109 Suppl 2:S81-5. doi: 10.1017/S0007114512004047.
PubMed 23360884Griffiths EA, Duffy LC, Schanbacher FL, Qiao H, Dryja D, Leavens A, Rossman J, Rich G, Dirienzo D, Ogra PL. In vivo effects of bifidobacteria and lactoferrin on gut endotoxin concentration and mucosal immunity in Balb/c mice. Dig Dis Sci. 2004 Apr;49(4):579-89. doi: 10.1023/b:ddas.0000026302.92898.ae.
PubMed 15185861He C, Shan Y, Song W. Targeting gut microbiota as a possible therapy for diabetes. Nutr Res. 2015 May;35(5):361-7. doi: 10.1016/j.nutres.2015.03.002. Epub 2015 Mar 14.
PubMed 25818484Kassaian N, Feizi A, Aminorroaya A, Jafari P, Ebrahimi MT, Amini M. The effects of probiotics and synbiotic supplementation on glucose and insulin metabolism in adults with prediabetes: a double-blind randomized clinical trial. Acta Diabetol. 2018 Oct;55(10):1019-1028. doi: 10.1007/s00592-018-1175-2. Epub 2018 Jun 22.
PubMed 29931423Kim YA, Keogh JB, Clifton PM. Probiotics, prebiotics, synbiotics and insulin sensitivity. Nutr Res Rev. 2018 Jun;31(1):35-51. doi: 10.1017/S095442241700018X. Epub 2017 Oct 17.
PubMed 29037268Kootte RS, Vrieze A, Holleman F, Dallinga-Thie GM, Zoetendal EG, de Vos WM, Groen AK, Hoekstra JB, Stroes ES, Nieuwdorp M. The therapeutic potential of manipulating gut microbiota in obesity and type 2 diabetes mellitus. Diabetes Obes Metab. 2012 Feb;14(2):112-20. doi: 10.1111/j.1463-1326.2011.01483.x. Epub 2011 Nov 22.
PubMed 21812894Larsen N, Vogensen FK, van den Berg FW, Nielsen DS, Andreasen AS, Pedersen BK, Al-Soud WA, Sorensen SJ, Hansen LH, Jakobsen M. Gut microbiota in human adults with type 2 diabetes differs from non-diabetic adults. PLoS One. 2010 Feb 5;5(2):e9085. doi: 10.1371/journal.pone.0009085.
PubMed 20140211
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Synbiotic on Intestinal Microbiota and HOMA-IR (Homeostatic Model Assessment of Insulin Resistance) on Obesity
- ClinicalTrials.gov ID
- NCT04642482
- Acronym / sponsor ID
- 0711201127
- Conditions
- Obesity, Insulin Resistance
- Keywords
- Intestinal Microbiota, Probiotic, Insulin Resistance, Obesity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Hasanuddin UniversityUniversity, hospital or other
- Study start
- 24 Sep 2019 (actual)
- Primary completion
- 26 Dec 2019 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 24 Nov 2020 (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.
Background :
There is a plausible relationship between microbial gut and insulin resistance. Intervention to prevent insulin resistance by modifying the microbial gut has been proposed but limited studies demonstrates the expected impact. One of the possible way to manipulate the microbial gut is the administration of synbiotic (prebiotic and probiotic).
Objective :
This study aim to address the impact of synbiotic administration to the microbial gut and insulin resistance.
Brief Methodology :
A Quasi Experimental study with multiple arms is conducted to healthy participants. All subjects will undergo a microbial gut taxonomic analysis using faecal sample and blood examination to determine the insulin resistance status (using Homeostatic Model Assessment for Insulin Resistance/HOMA-IR approach). Synbiotic will be given to intervention arm and active comparator will use maltodextrin. Repeated measurement will be conducted after 8 weeks and 12 weeks from the day of administration.
Hypothesis : A superiority trial hypothesis is applied, assuming that the synbiotic group will demonstrates higher variety of microbial gut and lower HOMA-IR level
Detailed description
Study Location :
This study will recruit the healthy participants from the university
Target Population:
Healthy Participants
General Study Design :
Quasi Experimental study with a comparator
Sample Size calculation :
Difference between two means of HOMA IR from pilot data (7) and standard deviation 2.9, with 5% Type I error, and 80% Power yielded a total of 16 participants for two arms
Management of Sample:
- Faecal Sample handling
- Patient should undergo 8 hours of fasting prior to faecal examination
- DNA Extraction
- Lysate preparation and centrifuge faecal sample
- Mixing lysate with sample
- Column wash
- DNA elution
- DNA storing
- DNA sequencing and analysis
- taxonomical analysis
- Fasting blood glucose
- Patient should undergo 8 hours of fasting prior to Fasting blood glucose
- Blood is taken from cubital vein
- Spectrometry is conducted based on the NADPH formation from the equation below D-glucose+ATP -----> Glucose-6-phospate+ADP Glucose-6-phospate+NAD ---- G-6-PDH ---> D-Gluconate-6 phospate+NADH+H
- Insulin level
- Centrifuge blood to obtain the serum
- The monoclonal anti-insulin antibody is given to the serum
- detection is based on the anti-insulin antibody and insulin complex formation
- Homeostatic Model Assessment for Insulin Resistance/ HOMA-IR value is calculated from glucose level multiply by insulin level and divided by 405.
Protection for adverse event
- All subjects are given the consent regarding the potential harm of synbiotic administration
- All subjects will follow the protocol of reporting the any adverse event (most likely, severe constipation)
- All subjects will be treated accordingly and hospitalisation if needed.
Statistical Analysis
- General Analysis : Intention To Treat (ITT)
- Propensity Score Matching will be conducted prior to intervention
- A repeated measure ANOVA will be performed, whereas Generalized Linear Mixed Model treating the intervention as dummy variable will be performed if ANOVA assumptions can not be fulfilled.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A multiple-arm study involves three different groups receiving synbiotic (probiotic + prebiotic) and placebo. Observation of intestinal microbiota and insulin resistance is observed in repeated measurement
| Arm | Type | Receives |
|---|---|---|
| Synbiotic | Experimental | Dietary Supplement: Synbiotic (Rillus)A fine powder to be taken orally consists of Viable cell 1,0 x 10^9 Colony Forming Unit of : * Lactobacillus plantarum 8,55 mg * Streptococcus thermophilus 8,55 mg * Bifidobacterium bifidum 2,55 mg * Fructooligosaccharide 480 mg * Additional components : isomalt, xylitol |
| Placebo | Active comparator | Drug: PlaceboA powder of 5 gram maltodextrin is given as active comparator, taken orally. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age above 18 years old
- Not receive antibiotic prescription within the last 6 months
Key exclusion criteria (5 listed)
- Taking medication that alters the blood sugar
- Taking probiotic or synbiotic product (such as yogurt)
- Participant who do not take the synbiotic intervention for more than 3 days consecutively
- incomplete follow up examination results
- Develop adverse effect
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 |
|---|---|---|
| Synbiotic (Rillus)Also: RillusParticipants in this group will be given a fine powder of synbiotic formula and should be taken orally without diluted with water. | Dietary supplement | Synbiotic |
| PlaceboAlso: MaltodextrinParticipants in this group will be given a fine powder of maltodextrin formula and should be taken orally without diluted with water. | Drug | Placebo |
Primary outcome
Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
Time frame: Changes of HOMA IR value from baseline to 8 weeks
a value representing the insulin resistance yielded by multiplying the blood glucose value and insulin value, then divided by 405 (considering the unit of values are in mg/dL not mmol)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2020.
- Background: PubMed 20815975Andreasen AS, Larsen N, Pedersen-Skovsgaard T, Berg RM, Moller K, Svendsen KD, Jakobsen M, Pedersen BK. Effects of Lactobacillus acidophilus NCFM on insulin sensitivity and the systemic inflammatory response in human subjects. Br J Nutr. 2010 Dec;104(12):1831-8. doi: 10.1017/S0007114510002874. Epub 2010 Sep 6.
- Background: PubMed 32119675Hagerty SL, Hutchison KE, Lowry CA, Bryan AD. An empirically derived method for measuring human gut microbiome alpha diversity: Demonstrated utility in predicting health-related outcomes among a human clinical sample. PLoS One. 2020 Mar 2;15(3):e0229204. doi: 10.1371/journal.pone.0229204. eCollection 2020.
- Background: PubMed 23947604Brahe LK, Astrup A, Larsen LH. Is butyrate the link between diet, intestinal microbiota and obesity-related metabolic diseases? Obes Rev. 2013 Dec;14(12):950-9. doi: 10.1111/obr.12068. Epub 2013 Aug 16.
- Background: PubMed 23037511Bermudez-Brito M, Plaza-Diaz J, Munoz-Quezada S, Gomez-Llorente C, Gil A. Probiotic mechanisms of action. Ann Nutr Metab. 2012;61(2):160-74. doi: 10.1159/000342079. Epub 2012 Oct 2.
- Background: PubMed 17823788Cani PD, Neyrinck AM, Fava F, Knauf C, Burcelin RG, Tuohy KM, Gibson GR, Delzenne NM. Selective increases of bifidobacteria in gut microflora improve high-fat-diet-induced diabetes in mice through a mechanism associated with endotoxaemia. Diabetologia. 2007 Nov;50(11):2374-83. doi: 10.1007/s00125-007-0791-0. Epub 2007 Sep 6.
- Background: PubMed 19442172Cani PD, Delzenne NM. The role of the gut microbiota in energy metabolism and metabolic disease. Curr Pharm Des. 2009;15(13):1546-58. doi: 10.2174/138161209788168164.
- Background: PubMed 26600968Chakraborti CK. New-found link between microbiota and obesity. World J Gastrointest Pathophysiol. 2015 Nov 15;6(4):110-9. doi: 10.4291/wjgp.v6.i4.110.
- Background: PubMed 23985870Le Chatelier E, Nielsen T, Qin J, Prifti E, Hildebrand F, Falony G, Almeida M, Arumugam M, Batto JM, Kennedy S, Leonard P, Li J, Burgdorf K, Grarup N, Jorgensen T, Brandslund I, Nielsen HB, Juncker AS, Bertalan M, Levenez F, Pons N, Rasmussen S, Sunagawa S, Tap J, Tims S, Zoetendal EG, Brunak S, Clement K, Dore J, Kleerebezem M, Kristiansen K, Renault P, Sicheritz-Ponten T, de Vos WM, Zucker JD, Raes J, Hansen T; MetaHIT consortium; Bork P, Wang J, Ehrlich SD, Pedersen O. Richness of human gut microbiome correlates with metabolic markers. Nature. 2013 Aug 29;500(7464):541-6. doi: 10.1038/nature12506.
- Background: PubMed 23360884Delzenne NM, Neyrinck AM, Cani PD. Gut microbiota and metabolic disorders: How prebiotic can work? Br J Nutr. 2013 Jan;109 Suppl 2:S81-5. doi: 10.1017/S0007114512004047.
- Background: PubMed 15185861Griffiths EA, Duffy LC, Schanbacher FL, Qiao H, Dryja D, Leavens A, Rossman J, Rich G, Dirienzo D, Ogra PL. In vivo effects of bifidobacteria and lactoferrin on gut endotoxin concentration and mucosal immunity in Balb/c mice. Dig Dis Sci. 2004 Apr;49(4):579-89. doi: 10.1023/b:ddas.0000026302.92898.ae.
- Background: PubMed 25818484He C, Shan Y, Song W. Targeting gut microbiota as a possible therapy for diabetes. Nutr Res. 2015 May;35(5):361-7. doi: 10.1016/j.nutres.2015.03.002. Epub 2015 Mar 14.
- Background: PubMed 29931423Kassaian N, Feizi A, Aminorroaya A, Jafari P, Ebrahimi MT, Amini M. The effects of probiotics and synbiotic supplementation on glucose and insulin metabolism in adults with prediabetes: a double-blind randomized clinical trial. Acta Diabetol. 2018 Oct;55(10):1019-1028. doi: 10.1007/s00592-018-1175-2. Epub 2018 Jun 22.
- Individual participant dataSharing planned: No
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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.
Nasrum Massi, Prof. principal investigator
Hasanuddin University
Andi Anggeraini principal investigator
Hasanuddin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Synbiotic (Rillus) in people with Obesity and Insulin Resistance, run by Hasanuddin University at 1 site in Indonesia.
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 5 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: finished, as of the sponsor's last update on 24 Nov 2020. 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 Indonesia. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) (time frame: Changes of HOMA IR value from baseline to 8 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 NCT04642482, which also lists 17 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 24 Nov 2020; AzTrials last refreshed its copy on 7 Nov 2026.