Childhood ObesityNCT05423015
Assessment of the Effects of Synbiotic on Gut Microbiota Composition in Scholars With Overweight
A study testing Lactobacillus casei strain Shirota, Lactobacillus casei strain Shirota plus inulin and Lactobacillus casei strain Shirota plus fructans from A. salmiana in people with Childhood Obesity and Childhood Overweight, run by Universidad Autonoma de San Luis Potosí at 1 site in Mexico.
Trial summary
This study was a randomized, double-blind controlled protocol in children overweight aged 6-11 years. This study aimed to evaluate the effect of consuming fermented milk products containing Lactobacillus casei strain Shirota (LcS), as a probiotic enriched with prebiotic fructans from A. Read more about this study
- Who is it for?
- Ages 6 to 11 years
- Conditions the study is for
- Childhood Obesity, Childhood Overweight
- What is being tested?
- Lactobacillus casei strain Shirota, Lactobacillus casei strain Shirota plus inulin and Lactobacillus casei strain Shirota plus fructans from A. salmiana
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteMexico
- Study dates
- 21 Jul 2017to 9 Oct 2017
- 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 6 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children were overweight or obese, according to the World Health Organization (≥85th body mass index (BMI) percentile for overweight, and ≥95th BMI percentile for obesity).
Who cannot join
- Any known infections, systemic diseases or metabolic diseases, and use of any prescribed medications or antibiotics in the one month before randomization and during the trial.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Facultad de Ciencias Químicas, Universidad Autónoma de San Luis Potosí
San Luis Potosí City, 78210
About this study
Official title: Elaboration and Assessment of the Effects of Synbiotic on Gut Microbiota Composition of Scholars With Overweight
This study was a randomized, double-blind controlled protocol in children overweight aged 6-11 years. This study aimed to evaluate the effect of consuming fermented milk products containing Lactobacillus casei strain Shirota (LcS), as a probiotic enriched with prebiotic fructans from A. salmiana or inulin-like standard commercial prebiotic to improve the gut microbiota modulation. After providing detailed information, written informed consent was obtained from parents and written and oral assent from participants before the initial test day. Children were eligible for inclusion in the trial if they were overweight according to the World Health Organization (≥85th body mass index (BMI) percentile for overweight). The trial took place in three full-time elementary schools in San Luis Potosí, México, and the screening of the prospective participants took place up to 1 week prior to the randomization. Children were evaluated over a 6-week intervention period receiving different fermented milk products
Read the detailed description
Male and female children between the ages of 6- 10 years old were recruited from three schools located in San Luis Potosi, Mexico. According to the World Health Organization, children with overweight were requested to participate and were voluntarily recruited.
After providing detailed information, written informed consent was obtained from parents and written and oral assent from participants before the initial test day. The trial investigated the effect of daily intake of fermented milk products containing Lactobacillus casei strain Shirota (LcS), LcS plus inulin (LcS+inulin), and LcS plus fructans from A. salmiana (LcS+fructans) on gut microbiota composition. The trial protocol was conducted according to the principles of the Declaration of Helsinki. It was approved by the Ethical Committee on Human Experimentation of the State Committee of Health Education and Research of the Health Secretary in San Luis Potosi (register number SLP/012-2017).
- Conditions
- Childhood Obesity, Childhood Overweight
- Being tested
- Lactobacillus casei strain Shirota, Lactobacillus casei strain Shirota plus inulin, Lactobacillus casei strain Shirota plus fructans from A. salmiana
- Keywords
- Microbiota, Probiotic, Fermented milk product, Synbiotic
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus casei strain ShirotaDietary supplement
Also called L. casei Shirota, LcS, Probiotic product
Probiotic product were made in a Class II biosafety cabinet. Fifteen milliliters of the fermented milk food wich contains LcS were taken with a sterile syringe, and, at a subsequent time, 15 mL of sterile water were added to the probiotic product.
Lactobacillus casei strain Shirota plus inulinDietary supplement
Also called LcS + inulin, Synbiotic product, Syn-inulin
The Syn-inulin products were made in a Class II biosafety cabinet. Fifteen milliliters of the fermented milk food wich contains LcS were taken with a sterile syringe, and, at a subsequent time, 3 g of inulin (BENEO GmbH) were diluted in 15 mL of sterile water and added to Syn-inulin products.
Lactobacillus casei strain Shirota plus fructans from A. salmianaDietary supplement
Also called Lactobacillus casei strain Shirota plus A.salmiana, LcS + fructans, LcS + A. salmiana, Synbiotic product
The Syn-A. salmiana products were made in a Class II biosafety cabinet. Fifteen milliliters of the fermented milk food wich contains LcS were taken with a sterile syringe, and, at a subsequent time, 3 g of fructans from A. salmiana were diluted in 15 mL of sterile water and added to Syn-A.salmiana products.
| Study group | Role | What they receive |
|---|---|---|
| Lactobacillus casei (Probiotic) | Experimental | Consist in a commercial fermented milk food (Soful LT), which Lactobacillus casei was used as a primary base (probiotic product) Receives: Dietary Supplement: Lactobacillus casei strain Shirota |
| L. casei strain Shirota plus inulin (Syn-Inulin) | Experimental | Consist in a commercial fermented milk food (Soful LT), which Lactobacillus casei was used as a primary base (probiotic product) and enriched with 3g of inulin. Receives: Dietary Supplement: Lactobacillus casei strain Shirota plus inulin |
| L. casei strain Shirota plus fructans from A. salmiana (Syn-A. salmiana) | Experimental | Consist in a commercial fermented milk food (Soful LT), which Lactobacillus casei was used as a primary base (probiotic product) and enriched with 3g of fructans from A. salmiana. Receives: Dietary Supplement: Lactobacillus casei strain Shirota plus fructans from A. salmiana |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gut bacteria associated with changes of the intervention group
Comparison of the log2ratio of the genera and the abundance of amplicon sequence variants across the different treatments.
Measured: Abundance of microbes and relative number of taxa in samples through study completion, 6 weeks intervention of each group
Effect of probiotic and synbiotic products intervention on the BMI z-score
Assesment of BMI-Z score changes
Measured: Comparison of BMI-Z score through study completion, 6 weeks intervention of each group.
Effect of probiotic and synbiotic products intervention on the fat percentage
Assesment of fat percentage changes
Measured: Comparison of fat percentage through study completion, 6 weeks intervention of each group.
Effect of probiotic and synbiotic products intervention on waist and neck circunference
Assesment of waist and neck circunference changes
Measured: Comparison of waist and neck circunference through study completion, 6 weeks intervention of each group.
Effect of probiotic and synbiotic products intervention on glucose, triglycerides and cholesterol serum levels
Assesment of glucose, triglycerides and cholesterol serum levels changes
Measured: Comparison of glucose, triglycerides and cholesterol serum levels through study completion, 6 weeks intervention of each group.
Secondary outcomes (1)
Effect of probiotic and synbiotic products intervention on Free Fatty Acid Receptors (FFAR) 2 and 3 levels
Assessment of mRNA levels of FFAR2 and FFAR3 in the peripheral blood mononuclear cells changes
Measured: Comparison of mRNA levels of FFAR2 and FFAR3 through study completion, 6 weeks intervention of each group.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start21 Jul 2017
- Primary completion2 Oct 2017
- Study completion9 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Childhood 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Randomised, double blind controlled protocol in children with overweight or obesity aged 6-11 years
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Autonoma de San Luis Potosí
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diana Patricia Portales-Pérez, Universidad Autonoma de San Luis Potosí
- Investigators
- Diana Patricia Portales-Pérez, phD, Principal investigator, Universidad Autonoma de San Luis Potosí
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05423015
- Sponsor's protocol ID
- 201708
- Status last verified
- Jun 2022
- First submitted
- 9 Jun 2022
- Last updated
- 21 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nagata S, Asahara T, Ohta T, Yamada T, Kondo S, Bian L, Wang C, Yamashiro Y, Nomoto K. Effect of the continuous intake of probiotic-fermented milk containing Lactobacillus casei strain Shirota on fever in a mass outbreak of norovirus gastroenteritis and the faecal microflora in a health service facility for the aged. Br J Nutr. 2011 Aug;106(4):549-56. doi: 10.1017/S000711451100064X. Epub 2011 Apr 27.
PubMed 21521545Fernandes R, do Rosario VA, Mocellin MC, Kuntz MGF, Trindade EBSM. Effects of inulin-type fructans, galacto-oligosaccharides and related synbiotics on inflammatory markers in adult patients with overweight or obesity: A systematic review. Clin Nutr. 2017 Oct;36(5):1197-1206. doi: 10.1016/j.clnu.2016.10.003. Epub 2016 Oct 8.
PubMed 27771020Regalado-Renteria E, Aguirre-Rivera JR, Godinez-Hernandez CI, Garcia-Lopez JC, Oros-Ovalle AC, Martinez-Gutierrez F, Martinez-Martinez M, Ratering S, Schnell S, Ruiz-Cabrera MA, Juarez-Flores BI. Effects of Agave Fructans, Inulin, and Starch on Metabolic Syndrome Aspects in Healthy Wistar Rats. ACS Omega. 2020 May 6;5(19):10740-10749. doi: 10.1021/acsomega.0c00272. eCollection 2020 May 19.
PubMed 32455193Larsen N, Vogensen FK, Gobel RJ, Michaelsen KF, Forssten SD, Lahtinen SJ, Jakobsen M. Effect of Lactobacillus salivarius Ls-33 on fecal microbiota in obese adolescents. Clin Nutr. 2013 Dec;32(6):935-40. doi: 10.1016/j.clnu.2013.02.007. Epub 2013 Mar 4.
PubMed 23510724Martinez-Gutierrez, F., Ratering, S., Juárez-Flores, B., et al. Potential use of Agave salmiana as a prebiotic that stimulates the growth of probiotic bacteria. Lwt, 2017; 84:151-159.
Nagata S, Chiba Y, Wang C, Yamashiro Y. The effects of the Lactobacillus casei strain on obesity in children: a pilot study. Benef Microbes. 2017 Aug 24;8(4):535-543. doi: 10.3920/BM2016.0170. Epub 2017 Jun 16.
PubMed 28618860Safavi M, Farajian S, Kelishadi R, Mirlohi M, Hashemipour M. The effects of synbiotic supplementation on some cardio-metabolic risk factors in overweight and obese children: a randomized triple-masked controlled trial. Int J Food Sci Nutr. 2013 Sep;64(6):687-93. doi: 10.3109/09637486.2013.775224. Epub 2013 Mar 12.
PubMed 23477506Vega-Cardenas M, Martinez-Gutierrez F, Lara-Ramirez EE, Reynaga-Hernandez E, Yanez-Estrada L, Ratering S, Schnell S, Godinez-Hernandez CI, Vargas-Morales JM, Portales-Perez DP. Agave fructans enhance the effects of fermented milk products on obesity biomarkers: a randomised trial. Benef Microbes. 2023 Apr 18;14(2):153-164. doi: 10.3920/BM2022.0078. Epub 2023 Mar 1.
PubMed 36856122
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elaboration and Assessment of the Effects of Synbiotic on Gut Microbiota Composition of Scholars With Overweight
- ClinicalTrials.gov ID
- NCT05423015
- Acronym / sponsor ID
- 201708
- Conditions
- Childhood Obesity, Childhood Overweight
- Keywords
- Microbiota, Probiotic, Fermented milk product, Synbiotic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Universidad Autonoma de San Luis PotosíUniversity, hospital or other
- Study start
- 21 Jul 2017 (actual)
- Primary completion
- 2 Oct 2017 (actual)
- Study completion
- 9 Oct 2017 (actual)
- First posted
- 21 Jun 2022 (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 was a randomized, double-blind controlled protocol in children overweight aged 6-11 years. This study aimed to evaluate the effect of consuming fermented milk products containing Lactobacillus casei strain Shirota (LcS), as a probiotic enriched with prebiotic fructans from A. salmiana or inulin-like standard commercial prebiotic to improve the gut microbiota modulation. After providing detailed information, written informed consent was obtained from parents and written and oral assent from participants before the initial test day. Children were eligible for inclusion in the trial if they were overweight according to the World Health Organization (≥85th body mass index (BMI) percentile for overweight). The trial took place in three full-time elementary schools in San Luis Potosí, México, and the screening of the prospective participants took place up to 1 week prior to the randomization. Children were evaluated over a 6-week intervention period receiving different fermented milk products
Detailed description
Male and female children between the ages of 6- 10 years old were recruited from three schools located in San Luis Potosi, Mexico. According to the World Health Organization, children with overweight were requested to participate and were voluntarily recruited.
After providing detailed information, written informed consent was obtained from parents and written and oral assent from participants before the initial test day. The trial investigated the effect of daily intake of fermented milk products containing Lactobacillus casei strain Shirota (LcS), LcS plus inulin (LcS+inulin), and LcS plus fructans from A. salmiana (LcS+fructans) on gut microbiota composition. The trial protocol was conducted according to the principles of the Declaration of Helsinki. It was approved by the Ethical Committee on Human Experimentation of the State Committee of Health Education and Research of the Health Secretary in San Luis Potosi (register number SLP/012-2017).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Randomised, double blind controlled protocol in children with overweight or obesity aged 6-11 years
| Arm | Type | Receives |
|---|---|---|
| Lactobacillus casei (Probiotic) | Experimental | Dietary Supplement: Lactobacillus casei strain ShirotaConsist in a commercial fermented milk food (Soful LT), which Lactobacillus casei was used as a primary base (probiotic product) |
| L. casei strain Shirota plus inulin (Syn-Inulin) | Experimental | Dietary Supplement: Lactobacillus casei strain Shirota plus inulinConsist in a commercial fermented milk food (Soful LT), which Lactobacillus casei was used as a primary base (probiotic product) and enriched with 3g of inulin. |
| L. casei strain Shirota plus fructans from A. salmiana (Syn-A. salmiana) | Experimental | Dietary Supplement: Lactobacillus casei strain Shirota plus fructans from A. salmianaConsist in a commercial fermented milk food (Soful LT), which Lactobacillus casei was used as a primary base (probiotic product) and enriched with 3g of fructans from A. salmiana. |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children were overweight or obese, according to the World Health Organization (≥85th body mass index (BMI) percentile for overweight, and ≥95th BMI percentile for obesity).
Key exclusion criteria (1 listed)
- Any known infections, systemic diseases or metabolic diseases, and use of any prescribed medications or antibiotics in the one month before randomization and during the trial.
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 |
|---|---|---|
| Lactobacillus casei strain ShirotaAlso: L. casei Shirota, LcS, Probiotic productProbiotic product were made in a Class II biosafety cabinet. Fifteen milliliters of the fermented milk food wich contains LcS were taken with a sterile syringe, and, at a subsequent time, 15 mL of sterile water were added to the probiotic product. | Dietary supplement | Lactobacillus casei (Probiotic) |
| Lactobacillus casei strain Shirota plus inulinAlso: LcS + inulin, Synbiotic product, Syn-inulinThe Syn-inulin products were made in a Class II biosafety cabinet. Fifteen milliliters of the fermented milk food wich contains LcS were taken with a sterile syringe, and, at a subsequent time, 3 g of inulin (BENEO GmbH) were diluted in 15 mL of sterile water and added to Syn-inulin products. | Dietary supplement | L. casei strain Shirota plus inulin (Syn-Inulin) |
| Lactobacillus casei strain Shirota plus fructans from A. salmianaAlso: Lactobacillus casei strain Shirota plus A.salmiana, LcS + fructans, LcS + A. salmiana, Synbiotic productThe Syn-A. salmiana products were made in a Class II biosafety cabinet. Fifteen milliliters of the fermented milk food wich contains LcS were taken with a sterile syringe, and, at a subsequent time, 3 g of fructans from A. salmiana were diluted in 15 mL of sterile water and added to Syn-A.salmiana products. | Dietary supplement | L. casei strain Shirota plus fructans from A. salmiana (Syn-A. salmiana) |
Primary outcome
Gut bacteria associated with changes of the intervention group
Time frame: Abundance of microbes and relative number of taxa in samples through study completion, 6 weeks intervention of each group
Comparison of the log2ratio of the genera and the abundance of amplicon sequence variants across the different treatments.
Effect of probiotic and synbiotic products intervention on the BMI z-score
Time frame: Comparison of BMI-Z score through study completion, 6 weeks intervention of each group.
Assesment of BMI-Z score changes
Effect of probiotic and synbiotic products intervention on the fat percentage
Time frame: Comparison of fat percentage through study completion, 6 weeks intervention of each group.
Assesment of fat percentage changes
Effect of probiotic and synbiotic products intervention on waist and neck circunference
Time frame: Comparison of waist and neck circunference through study completion, 6 weeks intervention of each group.
Assesment of waist and neck circunference changes
Effect of probiotic and synbiotic products intervention on glucose, triglycerides and cholesterol serum levels
Time frame: Comparison of glucose, triglycerides and cholesterol serum levels through study completion, 6 weeks intervention of each group.
Assesment of glucose, triglycerides and cholesterol serum levels changes
1 secondary outcome
Effect of probiotic and synbiotic products intervention on Free Fatty Acid Receptors (FFAR) 2 and 3 levels
Time frame: Comparison of mRNA levels of FFAR2 and FFAR3 through study completion, 6 weeks intervention of each group.
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 21 Jun 2022.
- Background: PubMed 21521545Nagata S, Asahara T, Ohta T, Yamada T, Kondo S, Bian L, Wang C, Yamashiro Y, Nomoto K. Effect of the continuous intake of probiotic-fermented milk containing Lactobacillus casei strain Shirota on fever in a mass outbreak of norovirus gastroenteritis and the faecal microflora in a health service facility for the aged. Br J Nutr. 2011 Aug;106(4):549-56. doi: 10.1017/S000711451100064X. Epub 2011 Apr 27.
- Background: PubMed 27771020Fernandes R, do Rosario VA, Mocellin MC, Kuntz MGF, Trindade EBSM. Effects of inulin-type fructans, galacto-oligosaccharides and related synbiotics on inflammatory markers in adult patients with overweight or obesity: A systematic review. Clin Nutr. 2017 Oct;36(5):1197-1206. doi: 10.1016/j.clnu.2016.10.003. Epub 2016 Oct 8.
- Background: PubMed 32455193Regalado-Renteria E, Aguirre-Rivera JR, Godinez-Hernandez CI, Garcia-Lopez JC, Oros-Ovalle AC, Martinez-Gutierrez F, Martinez-Martinez M, Ratering S, Schnell S, Ruiz-Cabrera MA, Juarez-Flores BI. Effects of Agave Fructans, Inulin, and Starch on Metabolic Syndrome Aspects in Healthy Wistar Rats. ACS Omega. 2020 May 6;5(19):10740-10749. doi: 10.1021/acsomega.0c00272. eCollection 2020 May 19.
- Background: PubMed 23510724Larsen N, Vogensen FK, Gobel RJ, Michaelsen KF, Forssten SD, Lahtinen SJ, Jakobsen M. Effect of Lactobacillus salivarius Ls-33 on fecal microbiota in obese adolescents. Clin Nutr. 2013 Dec;32(6):935-40. doi: 10.1016/j.clnu.2013.02.007. Epub 2013 Mar 4.
- BackgroundMartinez-Gutierrez, F., Ratering, S., Juárez-Flores, B., et al. Potential use of Agave salmiana as a prebiotic that stimulates the growth of probiotic bacteria. Lwt, 2017; 84:151-159.
- Background: PubMed 28618860Nagata S, Chiba Y, Wang C, Yamashiro Y. The effects of the Lactobacillus casei strain on obesity in children: a pilot study. Benef Microbes. 2017 Aug 24;8(4):535-543. doi: 10.3920/BM2016.0170. Epub 2017 Jun 16.
- Background: PubMed 23477506Safavi M, Farajian S, Kelishadi R, Mirlohi M, Hashemipour M. The effects of synbiotic supplementation on some cardio-metabolic risk factors in overweight and obese children: a randomized triple-masked controlled trial. Int J Food Sci Nutr. 2013 Sep;64(6):687-93. doi: 10.3109/09637486.2013.775224. Epub 2013 Mar 12.
- Derived from this study: PubMed 36856122Vega-Cardenas M, Martinez-Gutierrez F, Lara-Ramirez EE, Reynaga-Hernandez E, Yanez-Estrada L, Ratering S, Schnell S, Godinez-Hernandez CI, Vargas-Morales JM, Portales-Perez DP. Agave fructans enhance the effects of fermented milk products on obesity biomarkers: a randomised trial. Benef Microbes. 2023 Apr 18;14(2):153-164. doi: 10.3920/BM2022.0078. Epub 2023 Mar 1.
- 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.
Diana Patricia Portales-Pérez, phD principal investigator
Universidad Autonoma de San Luis Potosí
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactobacillus casei strain Shirota, Lactobacillus casei strain Shirota plus inulin and Lactobacillus casei strain Shirota plus fructans from A. salmiana in people with Childhood Obesity and Childhood Overweight, run by Universidad Autonoma de San Luis Potosí at 1 site in Mexico.
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 1 inclusion and 1 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 21 Jun 2022. 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 Mexico. 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.
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?
Gut bacteria associated with changes of the intervention group (time frame: Abundance of microbes and relative number of taxa in samples through study completion, 6 weeks intervention of each group). The study lists 5 primary outcomes in all. 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 NCT05423015, which also lists 8 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 21 Jun 2022.