Signs and Symptoms, DigestivePhase 4ProbiatopNCT05603403

Efficacy And Safety Of Probiatop In The Treatment Of Digestive Symptoms

A Phase 4 study testing Probiatop in people with Signs and Symptoms, Digestive, run by Azidus Brasil at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Signs and Symptoms, Digestive
What is being tested?: Probiatop
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 150 participants
Where: 1 siteBrazil
Study dates: 20 Oct 2022to 15 Mar 2023
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
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female gender;
Age ≥ 18 years;
BMI ≥ 18, 5 ≤ 29.9 Kg/m2;
Complaint of recurrent digestive symptoms for at least 3 months with value ≥ 21 of the sum of questions: 6, 7, 8, 9, 10, 11, 12, 13, 14, and 15 of the GSRS in frequency or intensity separately.

Who cannot join

Extreme eating habits for which the primary intervention is dietary re-education: more than 7 of the of the 14 main meals of the week (lunch and dinner) based on ultra-processed products (industrial formulations formulations such as: filled cookies, "packaged" snacks packaged" snacks, soft drinks and "instant" noodles, frozen frozen and ready-to-eat products such as pasta, pizzas hamburgers, nuggets, sausages, etc) or "fast food" or average consumption of soft drinks exceeding 2 glasses per day.
Alcoholism (DSM V): disorder defined as the repetition problems resulting from the use of alcohol that lead to clinically significant clinically significant impairment and/or suffering;
Diabetes mellitus type I or II;
Chronic diarrhea with signs of malabsorption (weight loss bulky and exceptionally smelly stools), AND/OR bleeding, AND/OR presence of mucus in the stool, bleeding without diarrhea;
Weight loss ≥ 10% in the past 6 months;
Any recent change in eating habit, including veganism;

Show all 13Show fewer

Clinically significant illnesses at the discretion of the Investigator;
Use of medications or supplements that may modify gastrointestinal function in the 30 days prior to randomization, especially proton pump inhibitors antacids, laxatives, constipating agents (loperamide, racecadotrilla, tricyclic antidepressants), other probiotics and prebiotics (containing dietary fiber including inulin, resistant starch, cellulose, oligofructose, fiber oligofructose, soy fiber, polydextrose, Kefir, Kombucha, and others);
Use of antibiotics in the 3 months prior to randomization for any indications, including Helicobacter pylori;
History of digestive surgery;
Active cancer or cancer under treatment in the 6 months prior to randomization, except operated basal cell carcinoma;
History of allergy or hypersensitivity to probiotics or components of the formula;
Pregnant and lactating women.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

A2Z Clinical Centro Avancado de Pesquisa Clinica Eireli
Valinhos, São Paulo, 13271-130

Other trials in Brazil

About this study

Official title: Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial Placebo-Controlled Clinical Trial To Evaluate The Efficacy And Safety Of Probiatop In The Treatment Of Digestive Symptoms

A Multicenter, Randomized, Double-blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Probiatop in the Treatment of Digestive Symptoms. Phase IV. The casuistic presented in this protocol is 150 participants randomized at a 1:1 ratio (75 receiving Probiatop and 75 receiving placebo), balanced by age, sex, prebiotic intake* and summation of the Gastrointestinal Symptom Rating Scale (GSRS) questions related to the domains of diarrhea (questions 11, 12, and 14), indigestion (questions 6, 7, 8, and 9), and constipation (questions 10, 13, and 15) separated by intensity and frequency. Participants with recurrent digestive symptoms for at least 3 months, with a score of 21 on the sum of questions 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 of the GSRS (corresponding to the domains diarrhea, indigestion and constipation) will be randomized to Probiatop or placebo.

Read the detailed description

This is a Phase IV clinical trial that will evaluate the efficacy and safety of Probiatop (investigational product). Participants with recurrent digestive symptoms for at least 3 months, with a score of 21 on the sum of questions: 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 of the GSRS questionnaire (corresponding to the domains diarrhea, indigestion and constipation) will be randomized to Probiatop or placebo. It will also be applied by electronic means (whatsapp link) on D7, D21 and D35. On these days participants will also be contacted by telemedicine to collect adverse events adverse events and data on concomitant medication. Treatment will be discontinued on D42. On D70 the participant will again be contacted by telemedicine for final data collection.

Product under investigation and dosage: Probiatop composition: association of probiotic strains containing 1 g/sachet of 1 x 109 CFU Bifidobacterium lactis HN019 (ATCC SD 5674), 1 x 109 CFU Lactobacillus acidophilus NCFM (ATCC SD 5221), 1 x 109 CFU Lactobacillus rhamnosus HN001 / Lacticaseibacillus rhamnosus HN001 (ATCC SD 5675) and 1 x 109 CFU Lactobacillus paracasei Lpc-37 / Lacticaseibacillus paracasei Lpc-37 (ATCC SD 5275). Placebo composition: collagen

Conditions: Signs and Symptoms, Digestive
Being tested: Probiatop, Placebo
Keywords: Signs and Symptoms Digestive, Probiatop, Digestive Symptoms
Medical subject headings: Signs and Symptoms, Digestive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ProbiatopDrug
Also called Probiotic
1 sachet orally, 2 times a day, for 42 days
PlaceboOther
Also called Placebo Comparator
1 sachet orally, 2 times a day, for 42 days

Study groups in NCT05603403
Study group	Role	What they receive
Probiatop	Experimental	Probiotic used in the reconstitution and rebalancing of the intestinal microbiota. Association of probiotic strains containing 1 g/sachet of 1 x 109 Bifidobacterium lactis HN019, 1 x 109 Lactobacillus acidophilus, 1 x 109 Lactobacillus rhamnosus HN001 / Lacticaseibacillus rhamnosus HN001 and 1 x 109 Lactobacillus paracasei Lpc- 37 / Lacticaseibacillus paracasei Lpc-37. Receives: Drug: Probiatop
Hydrolized collagen	Placebo comparator	Hydrolyzed collagen is approved by Agência Nacional de Vigilância Sanitária (ANVISA) including for use in infants (ANVISA, IN NO. 28, OF JULY 26, 2018). Its use as a placebo is convenient, as it dissolves well in water, and promotes good masking. Based on literature surveys on hydrolyzed collagen and the intestinal microbiota, it was verified that the dose used (1 g) would not promote relevant functional impact in the context of the habitual Brazilian people diet. Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Clinical Outcome Measure: Efficacy
Multicriteria evaluation of the impact of Probiatop on gastrointestinal symptom reduction symptoms by the Gastrointestinal Symptom Rating Scale (GSRS).
Measured: 42 days

Secondary outcomes (2)

Clinical Outcome Measure: Safety
Evaluation of the impact of Probiatop on the reduction of each domain of the questionnaire Gastrointestinal Symptom Rating Scale (GSRS) - abdominal pain, reflux syndrome, diarrhea, indigestion and constipation.
Measured: 42 days
Clinical Outcome Measure: Safety
Incidence and severity of adverse reactions to Probiatop.
Measured: Day 0 to Day 42

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Oct 202215 Mar 2023

First posted2 Nov 2022
Study start20 Oct 2022
Primary completion15 Mar 2023
Study completion15 Mar 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (37)Papers the sponsor has linked to this study.
Other trials for Signs and Symptoms, DigestiveStudies 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: Randomised
Intervention model: Parallel groups
Model description: Investigational product (Probiatop) and Placebo
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 150 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05603403
Sponsor's protocol ID: PROFQM0422OR-IV
Other IDs: 60215522.6.1001.5412
Acronym: Probiatop
Status last verified: Mar 2024
First submitted: 20 Oct 2022
Last updated: 25 Mar 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: It is believed that after the data analysis and presentation to the National Commission on Research Ethics, all data will become public.

Publications

ANVISA, Instrução Normativa - IN Nº 28, DE 26 DE JULHO DE 2018. Estabelece as listas de constituintes, de limites de uso, de alegações e de rotulagem complementar dos suplementos alimentares. Almeida, L. B., C. B. Marinho, C. S. Souza and V. Cheib (2009).
Almeida, L. B., C. B. Marinho, C. S. Souza and V. Cheib (2009).
Bae JY, Kim JI, Park S, Yoo K, Kim IH, Joo W, Ryu BH, Park MS, Lee I, Park MS. Effects of Lactobacillus plantarum and Leuconostoc mesenteroides Probiotics on Human Seasonal and Avian Influenza Viruses. J Microbiol Biotechnol. 2018 Jun 28;28(6):893-901. doi: 10.4014/jmb.1804.04001.
PubMed 29847863
Blumstein DT, Levy K, Mayer E, Harte J. Gastrointestinal dysbiosis. Evol Med Public Health. 2014;2014(1):163. doi: 10.1093/emph/eou029. Epub 2014 Nov 20. No abstract available.
PubMed 25416734
Breton J, Galmiche M, Dechelotte P. Dysbiotic Gut Bacteria in Obesity: An Overview of the Metabolic Mechanisms and Therapeutic Perspectives of Next-Generation Probiotics. Microorganisms. 2022 Feb 16;10(2):452. doi: 10.3390/microorganisms10020452.
PubMed 35208906
Chen Y, Zhou J, Wang L. Role and Mechanism of Gut Microbiota in Human Disease. Front Cell Infect Microbiol. 2021 Mar 17;11:625913. doi: 10.3389/fcimb.2021.625913. eCollection 2021.
PubMed 33816335
Cremonini F, Di Caro S, Nista EC, Bartolozzi F, Capelli G, Gasbarrini G, Gasbarrini A. Meta-analysis: the effect of probiotic administration on antibiotic-associated diarrhoea. Aliment Pharmacol Ther. 2002 Aug;16(8):1461-7. doi: 10.1046/j.1365-2036.2002.01318.x.
PubMed 12182746
Cruchet S, Furnes R, Maruy A, Hebel E, Palacios J, Medina F, Ramirez N, Orsi M, Rondon L, Sdepanian V, Xochihua L, Ybarra M, Zablah RA. The use of probiotics in pediatric gastroenterology: a review of the literature and recommendations by Latin-American experts. Paediatr Drugs. 2015 Jun;17(3):199-216. doi: 10.1007/s40272-015-0124-6.
PubMed 25799959
de Almada CN, Nunes de Almada C, Martinez RC, Sant'Ana Ade S. Characterization of the intestinal microbiota and its interaction with probiotics and health impacts. Appl Microbiol Biotechnol. 2015 May;99(10):4175-99. doi: 10.1007/s00253-015-6582-5. Epub 2015 Apr 21.
PubMed 25895093
Ding RX, Goh WR, Wu RN, Yue XQ, Luo X, Khine WWT, Wu JR, Lee YK. Revisit gut microbiota and its impact on human health and disease. J Food Drug Anal. 2019 Jul;27(3):623-631. doi: 10.1016/j.jfda.2018.12.012. Epub 2019 Feb 1.
PubMed 31324279
Divella R, DE Palma G, Tufaro A, Pelagio G, Gadaleta-Caldarola G, Bringiotti R, Paradiso A. Diet, Probiotics and Physical Activity: The Right Allies for a Healthy Microbiota. Anticancer Res. 2021 Jun;41(6):2759-2772. doi: 10.21873/anticanres.15057.
PubMed 34083266
Fan Y, Pedersen O. Gut microbiota in human metabolic health and disease. Nat Rev Microbiol. 2021 Jan;19(1):55-71. doi: 10.1038/s41579-020-0433-9. Epub 2020 Sep 4.
PubMed 32887946
Ford AC, Harris LA, Lacy BE, Quigley EMM, Moayyedi P. Systematic review with meta-analysis: the efficacy of prebiotics, probiotics, synbiotics and antibiotics in irritable bowel syndrome. Aliment Pharmacol Ther. 2018 Nov;48(10):1044-1060. doi: 10.1111/apt.15001. Epub 2018 Oct 8.
PubMed 30294792
Fraher MH, O'Toole PW, Quigley EM. Techniques used to characterize the gut microbiota: a guide for the clinician. Nat Rev Gastroenterol Hepatol. 2012 Mar 27;9(6):312-22. doi: 10.1038/nrgastro.2012.44.
PubMed 22450307
Ganji-Arjenaki M, Rafieian-Kopaei M. Probiotics are a good choice in remission of inflammatory bowel diseases: A meta analysis and systematic review. J Cell Physiol. 2018 Mar;233(3):2091-2103. doi: 10.1002/jcp.25911. Epub 2017 May 3.
PubMed 28294322

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Signs and Symptoms, Digestive trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial Placebo-Controlled Clinical Trial To Evaluate The Efficacy And Safety Of Probiatop In The Treatment Of Digestive Symptoms
ClinicalTrials.gov ID: NCT05603403
Acronym / sponsor ID: Probiatop / PROFQM0422OR-IV
Conditions: Signs and Symptoms, Digestive
Keywords: Signs and Symptoms Digestive, Probiatop, Digestive Symptoms
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 150 participants (actual)
Lead sponsor: Azidus BrasilIndustry (pharma, biotech, devices)
Collaborators: Farmoquimica S.A.
Study start: 20 Oct 2022 (actual)
Primary completion: 15 Mar 2023 (actual)
Study completion: 15 Mar 2023 (actual)
First posted: 2 Nov 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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2
Model description: Investigational product (Probiatop) and Placebo

Arm	Type	Receives
Probiatop	Experimental	Drug: ProbiatopProbiotic used in the reconstitution and rebalancing of the intestinal microbiota. Association of probiotic strains containing 1 g/sachet of 1 x 109 Bifidobacterium lactis HN019, 1 x 109 Lactobacillus acidophilus, 1 x 109 Lactobacillus rhamnosus HN001 / Lacticaseibacillus rhamnosus HN001 and 1 x 109 Lactobacillus paracasei Lpc- 37 / Lacticaseibacillus paracasei Lpc-37.
Hydrolized collagen	Placebo comparator	Other: PlaceboHydrolyzed collagen is approved by Agência Nacional de Vigilância Sanitária (ANVISA) including for use in infants (ANVISA, IN NO. 28, OF JULY 26, 2018). Its use as a placebo is convenient, as it dissolves well in water, and promotes good masking. Based on literature surveys on hydrolyzed collagen and the intestinal microbiota, it was verified that the dose used (1 g) would not promote relevant functional impact in the context of the habitual Brazilian people diet.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Male or female gender;
Age ≥ 18 years;
BMI ≥ 18, 5 ≤ 29.9 Kg/m2;
Complaint of recurrent digestive symptoms for at least 3 months with value ≥ 21 of the sum of questions: 6, 7, 8, 9, 10, 11, 12, 13, 14, and 15 of the GSRS in frequency or intensity separately.

Key exclusion criteria (13 listed)

Extreme eating habits for which the primary intervention is dietary re-education: more than 7 of the of the 14 main meals of the week (lunch and dinner) based on ultra-processed products (industrial formulations formulations such as: filled cookies, "packaged" snacks packaged" snacks, soft drinks and "instant" noodles, frozen frozen and ready-to-eat products such as pasta, pizzas hamburgers, nuggets, sausages, etc) or "fast food" or average consumption of soft drinks exceeding 2 glasses per day.
Alcoholism (DSM V): disorder defined as the repetition problems resulting from the use of alcohol that lead to clinically significant clinically significant impairment and/or suffering;
Diabetes mellitus type I or II;
Chronic diarrhea with signs of malabsorption (weight loss bulky and exceptionally smelly stools), AND/OR bleeding, AND/OR presence of mucus in the stool, bleeding without diarrhea;
Weight loss ≥ 10% in the past 6 months;

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
ProbiatopAlso: Probiotic1 sachet orally, 2 times a day, for 42 days	Drug	Probiatop
PlaceboAlso: Placebo Comparator1 sachet orally, 2 times a day, for 42 days	Other	Hydrolized collagen

Primary outcome

Clinical Outcome Measure: Efficacy
Time frame: 42 days
Multicriteria evaluation of the impact of Probiatop on gastrointestinal symptom reduction symptoms by the Gastrointestinal Symptom Rating Scale (GSRS).

2 secondary outcomes

Clinical Outcome Measure: Safety
Time frame: 42 days
Clinical Outcome Measure: Safety
Time frame: Day 0 to Day 42

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 25 Mar 2024.
BackgroundANVISA, Instrução Normativa - IN Nº 28, DE 26 DE JULHO DE 2018. Estabelece as listas de constituintes, de limites de uso, de alegações e de rotulagem complementar dos suplementos alimentares. Almeida, L. B., C. B. Marinho, C. S. Souza and V. Cheib (2009).
BackgroundAlmeida, L. B., C. B. Marinho, C. S. Souza and V. Cheib (2009).
Background: PubMed 29847863Bae JY, Kim JI, Park S, Yoo K, Kim IH, Joo W, Ryu BH, Park MS, Lee I, Park MS. Effects of Lactobacillus plantarum and Leuconostoc mesenteroides Probiotics on Human Seasonal and Avian Influenza Viruses. J Microbiol Biotechnol. 2018 Jun 28;28(6):893-901. doi: 10.4014/jmb.1804.04001.
Background: PubMed 25416734Blumstein DT, Levy K, Mayer E, Harte J. Gastrointestinal dysbiosis. Evol Med Public Health. 2014;2014(1):163. doi: 10.1093/emph/eou029. Epub 2014 Nov 20. No abstract available.
Background: PubMed 35208906Breton J, Galmiche M, Dechelotte P. Dysbiotic Gut Bacteria in Obesity: An Overview of the Metabolic Mechanisms and Therapeutic Perspectives of Next-Generation Probiotics. Microorganisms. 2022 Feb 16;10(2):452. doi: 10.3390/microorganisms10020452.
Background: PubMed 33816335Chen Y, Zhou J, Wang L. Role and Mechanism of Gut Microbiota in Human Disease. Front Cell Infect Microbiol. 2021 Mar 17;11:625913. doi: 10.3389/fcimb.2021.625913. eCollection 2021.
Background: PubMed 12182746Cremonini F, Di Caro S, Nista EC, Bartolozzi F, Capelli G, Gasbarrini G, Gasbarrini A. Meta-analysis: the effect of probiotic administration on antibiotic-associated diarrhoea. Aliment Pharmacol Ther. 2002 Aug;16(8):1461-7. doi: 10.1046/j.1365-2036.2002.01318.x.
Background: PubMed 25799959Cruchet S, Furnes R, Maruy A, Hebel E, Palacios J, Medina F, Ramirez N, Orsi M, Rondon L, Sdepanian V, Xochihua L, Ybarra M, Zablah RA. The use of probiotics in pediatric gastroenterology: a review of the literature and recommendations by Latin-American experts. Paediatr Drugs. 2015 Jun;17(3):199-216. doi: 10.1007/s40272-015-0124-6.
Background: PubMed 25895093de Almada CN, Nunes de Almada C, Martinez RC, Sant'Ana Ade S. Characterization of the intestinal microbiota and its interaction with probiotics and health impacts. Appl Microbiol Biotechnol. 2015 May;99(10):4175-99. doi: 10.1007/s00253-015-6582-5. Epub 2015 Apr 21.
Background: PubMed 31324279Ding RX, Goh WR, Wu RN, Yue XQ, Luo X, Khine WWT, Wu JR, Lee YK. Revisit gut microbiota and its impact on human health and disease. J Food Drug Anal. 2019 Jul;27(3):623-631. doi: 10.1016/j.jfda.2018.12.012. Epub 2019 Feb 1.
Background: PubMed 34083266Divella R, DE Palma G, Tufaro A, Pelagio G, Gadaleta-Caldarola G, Bringiotti R, Paradiso A. Diet, Probiotics and Physical Activity: The Right Allies for a Healthy Microbiota. Anticancer Res. 2021 Jun;41(6):2759-2772. doi: 10.21873/anticanres.15057.
Background: PubMed 32887946Fan Y, Pedersen O. Gut microbiota in human metabolic health and disease. Nat Rev Microbiol. 2021 Jan;19(1):55-71. doi: 10.1038/s41579-020-0433-9. Epub 2020 Sep 4.
Individual participant dataSharing planned: No. It is believed that after the data analysis and presentation to the National Commission on Research Ethics, all data will become public.

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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.

Regina Mayumi Doi, MD principal investigator

A2Z CLINICAL CENTRO AVANCADO DE PESQUISA CLINICA EIRELI

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 Probiatop in people with Signs and Symptoms, Digestive, run by Azidus Brasil at 1 site in Brazil.

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 4 inclusion and 13 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 25 Mar 2024. 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 Brazil. 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.

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?

Clinical Outcome Measure: Efficacy (time frame: 42 days). 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 NCT05603403, which also lists 37 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 25 Mar 2024.