Irritable Bowel SyndromeNCT05064930
The Efficacy of Single-strain Probiotics in Patients With Irritable Bowel Syndrome
A study testing Probiotic Bifidobacterium lactis and Probiotic Bacillus coagulans in people with Irritable Bowel Syndrome, run by Nordic Biotic Sp. z o.o. at 1 site in Poland.
Trial summary
Irritable bowel syndrome (IBS) is one of the most common, yet still not fully understood, gastrointestinal disorders in adults. One suspected etiology involves intestinal dysbiosis, i.e. both quantitative and qualitative alterations in intestinal microbiota composition, which affects the gut-brain axis. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Probiotic Bifidobacterium lactis and Probiotic Bacillus coagulans
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 sitePoland
- Study dates
- 1 Sep 2021to 31 Jul 2022
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Caucasian males and females;
- Age from 18 to 70 years, inclusive;
- Good physical and mental condition assessed based on the patient's history and physical examination;
- Laboratory test results (blood tests, including blood chemistry and antibody tests; and urinalysis) within the normal limits for the local laboratory or considered clinically insignificant by the study investigator;
- A voluntarily provided written informed consent;
- Being available throughout the duration of the study;
- Patients with IBS diagnosed based on the Rome IV criteria;
- Patients with any form of IBS of at least moderate severity assessed via the IBS-SSS (score >175).
Who cannot join
- Cardiovascular disorders: uncontrolled hypertension (blood pressure > 170/100 mmHg), cerebrovascular disease;
- Severe respiratory disorders (asthma, chronic obstructive pulmonary disease)
- Liver or kidney disease and unexplained blood chemistry abnormalities: serum creatinine of more than twice the upper limit of normal, serum aminotransferease (AST or ALT) levels more than twice the upper limit of normal;
- Gastrointestinal disorders other than IBS (including gastroenteritis, celiac disease, and bacterial infections or parasitic infestations confirmed either clinically or endoscopically);
- Endocrine disorders, including diabetes (fasting blood glucose > 11 mmol/L) and serum thyroid stimulating hormone (TSH) levels above normal;
- Severe neurological conditions, with psychosis;
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- Malignancy;
- Pregnancy or breastfeeding;
- Hypersensitivity to soy;
- Lactose intolerance that may explain the symptoms (i.e. the symptoms resolve or considerably subside in response to a lactose-free diet);
- The use of gastrointestinal motility stimulants or dietary fiber supplements during the 2 weeks preceding the clinical study;
- The use of antithrombotic agents;
- A surgical procedure scheduled during the course of the clinical study;
- Current probiotic use and refusal to undergo a 3-month washout period;
- Antibiotic therapy within the previous 3 months;
- The patients who receive antibiotics during the study will be excluded;
- Being included in another clinical study within the previous 3 months;
- History of alcohol or substance abuse.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of the Efficacy of Single-strain Probiotics in Patients With Irritable Bowel Syndrome - a Randomized Double-blind Placebo-controlled Study
Irritable bowel syndrome (IBS) is one of the most common, yet still not fully understood, gastrointestinal disorders in adults. One suspected etiology involves intestinal dysbiosis, i.e. both quantitative and qualitative alterations in intestinal microbiota composition, which affects the gut-brain axis. Probiotics are live microorganisms, which-administered at the right dose-are beneficial for human health; their mechanism of action involves modifying the gut microbiota. Clinical study reports document that probiotic administration is beneficial for patients with IBS. The ultimate clinical effects depend primarily on probiotic strain selection. Our research team evaluated a multi-strain probiotic formulation and a multi-strain synbiotic (a combination of probiotic strains with short-chain prebiotic fructooligosaccharides) formulation as part of two randomized placebo-controlled clinical trials in patients with IBS with predominant diarrhea. The results indicated a beneficial effect of these formulations on the clinical course of IBS assessed with the international IBS symptom severity scale (IBS-SSS), with each of the study formulations exhibiting efficacy in different fields. The formulation composed of a mixture of Bifidobacterium and Lactobacillus strains reduced the levels of pain and improved the quality of life, whereas the synbiotic formulation effectively improved bloating and had a beneficial effect on the general condition of the intestines. A systematic review and meta-analysis published in 2020 showed that high doses of single-strain formulations, particularly those containing Bifidobacterium or Lactobacillus strains, may be more effective in IBS patients. Other reports demonstrated a high efficacy of the new-generation probiotic Bacillus coagulans in IBS. Therefore, the main objective of this research project is to assess the efficacy of single-strain probiotics containing Bifidobacterium lactis or Bacillus coagulans in patients with IBS.
Read the detailed description
This is a randomized double-blind placebo-controlled trial included 120 adult patients, who had been diagnosed with IBS according to the Rome IV diagnostic criteria. The patients will receive orally a probiotic formulation containing Bifidobacterium lactis or Bacillus coagulans or placebo over a period of 12 weeks. Once the period of supplementation is completed, the patients will be followed-up for the subsequent 4 weeks. The patients included in the study will receive diaries, which they will complete daily. The patient's dairy will include information about the number of stools, stool consistency (assessed based on the Bristol Stool Form Scale) and IBS symptoms (abdominal pain, bloating, bowel urgency, and feeling of incomplete evacuation) rated in a 5-grade scale. The diary will also include information on any adverse events and the use of any new medications during the study. Once a week, the patients will be contacted by phone by interviewers who will collect the information recorded in the patient's diary.
During the first visit, the patients included in the study will be informed of the study procedure and educated on the phone exchanges with the interviewers. One week prior to study intervention, the patients will be asked to record their symptoms in their patient diaries every day. Subsequently, the patients will visit their study doctor every four weeks (from the beginning of the study intervention) in order to receive the next dose of the study formulation/placebo. During each study visit, the patients will be evaluated with the use of IBS-SSS and IBS Global Improvement Scale (IBS-GIS). The patients included in the study will undergo a hydrogen breath test for small intestinal bacterial overgrowth (SIBO) both prior to receiving the study formulation/placebo and 12 weeks later, after intervention is completed.
The study will last a total of 16 weeks from the moment the intervention is initiated (12 weeks of interventions and 4 weeks of follow-up).
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Probiotic Bifidobacterium lactis, Probiotic Bacillus coagulans, Placebo
- Keywords
- Probiotics
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic Bifidobacterium lactisDietary supplement
The probiotic will be administered orally over a period of 12 weeks.
Probiotic Bacillus coagulansDietary supplement
The probiotic will be administered orally over a period of 12 weeks.
PlaceboDietary supplement
Maltodextrin as a placebo will be administered orally over a period of 12 weeks. The taste and appearance of the placebo will be similar to those of the probiotic formulation.
| Study group | Role | What they receive |
|---|---|---|
| Bifidobacterium lactis | Active comparator | Probiotic formula contains 5x109 Bifidobacterium lactis Nordbiotic™ BI040 colony forming units (CFU)/capsule Receives: Dietary Supplement: Probiotic Bifidobacterium lactis |
| Bacillus coagulans | Active comparator | Probiotic formula contains 2x109 Bacillus coagulans Nordbiotic™BC300 colony forming units (CFU)/capsule Receives: Dietary Supplement: Probiotic Bacillus coagulans |
| Maltodextrin | Placebo comparator | Maltodextrin (starch hydrolisate) as a compound presents in probiotic formula. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in severity of IBS symptoms using IBS Severity Scoring System (IBS-SSS)
IBS-SSS is a 5-question survey that asks: 1. the severity of abdominal pain, 2. frequency of abdominal pain, 3. severity of abdominal distention, 4.dissatisfaction with bowel habit, and 5. interference with quality of life over the past 10 days. Subjects respond to each question on a 100-point visual analogue scale. Each of the five question generates a maximum score of 100 point, and total scores can range from 0-500 with higher scores indicating severe symptoms. A decrease of 50 points is associated with a clinically meaningful improvement.
Measured: From baseline at 4, 8, 12 weeks of intervention, and 4 weeks (16 weeks of the study) after intervention
Improvement of IBS global symptoms using Global Improvement Scale (IBS-GIS)
IBS-Global Improvement Scale assesses IBS symptoms using a patient-defined 7 point Likert scale ranging from symptoms substantially worse to substantially improved.
Patients answer the question "Have you felt any change in the severity of your symptoms over the past 7 days compared to how you felt before the medicine was given?
The answers are recorded based on the 7-point scale:
- = I feel that the symptoms have worsened significantly
- = I feel that the symptoms have moderately worsened
- = I feel that the symptoms have slightly worsened
- = I feel no change
- = I feel a slight improvement
- = I feel moderate improvement
- = I feel significant improvement IBS-GIS score indicates: improvement if is >4 or worsening if is<4, no change if is 4
Measured: From baseline at 4, 8, 12 weeks of intervention, and 4 weeks (16 weeks of the study) after intervention
Secondary outcomes (5)
Changes in number of stools
The number of stools per day assessed before intervention and then 3 times a week
Measured: From baseline for 12 weeks of intervention, and for 4 weeks after intervention
Changes in severity of pain
The severity of pain assessed before intervention and then 3 times a week using a patient-defined 5 point Likert scale: point 0 - no pain, and 1-4 the severity of pain with higher scores indicating worse pain.
Measured: From baseline for 12 weeks of intervention, and for 4 weeks after intervention
Changes in flatulence
The severity of flatulence assessed before intervention and then 3 times a week using a patient-defined 5 point Likert scale: point 0 - no flatulence/abdominal distension, and 1-4 the severity of flatulence/abdominal distension with higher scores indicating worse pain.
Measured: From baseline for 12 weeks of intervention, and for 4 weeks after intervention
Occurrence of side effects
Side effects will be pointed in patient's dairy and collected by phone by interviewers.
Measured: From baseline for 12 weeks of intervention
Changes in type of stools
The type of stools analyzed before intervention and then 3 times a week. Type of stools assessed using the Bristol Stool Scale (BSS). BSS is designed to classify faeces into seven groups: type 1-2 indicate constipation, type 3-4 are "normal" stools; type 5-7 indicate diarrhea. The type of stool will be assessed with 7-point numerical scale (range 1-7).
Measured: From baseline for 12 weeks of intervention, and for 4 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2021
- Study start1 Sep 2021
- Primary completion30 Jun 2022
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Irritable Bowel SyndromeStudies 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nordic Biotic Sp. z o.o.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medical University of Lublin
- Responsible party
- Principal investigator, Barbara Skrzydło-Radomańska, Nordic Biotic Sp. z o.o.
- Investigators
- Barbara Skrzydło-Radomańska, MD, PhD, Principal investigator, Medical University of Lublin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05064930
- Sponsor's protocol ID
- CT/NB/120/2020/PR-SS
- Status last verified
- Jul 2023
- First submitted
- 10 Sep 2021
- Last updated
- 7 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Skrzydlo-Radomanska B, Prozorow-Krol B, Kurzeja-Miroslaw A, Cichoz-Lach H, Laskowska K, Majsiak E, Bierla JB, Agnieszka S, Cukrowska B. The Efficacy and Safety of Single-Strain Probiotic Formulations Containing Bifidobacterium lactis or Bacillus coagulans in Adult Patients with Irritable Bowel Syndrome-A Randomized Double-Blind Placebo-Controlled Three-Arm Interventional Trial. J Clin Med. 2023 Jul 22;12(14):4838. doi: 10.3390/jcm12144838.
PubMed 37510953
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Efficacy of Single-strain Probiotics in Patients With Irritable Bowel Syndrome - a Randomized Double-blind Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT05064930
- Acronym / sponsor ID
- CT/NB/120/2020/PR-SS
- Conditions
- Irritable Bowel Syndrome
- Keywords
- Probiotics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Nordic Biotic Sp. z o.o.Industry (pharma, biotech, devices)
- Collaborators
- Medical University of Lublin
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 1 Oct 2021 (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.
Irritable bowel syndrome (IBS) is one of the most common, yet still not fully understood, gastrointestinal disorders in adults. One suspected etiology involves intestinal dysbiosis, i.e. both quantitative and qualitative alterations in intestinal microbiota composition, which affects the gut-brain axis. Probiotics are live microorganisms, which-administered at the right dose-are beneficial for human health; their mechanism of action involves modifying the gut microbiota. Clinical study reports document that probiotic administration is beneficial for patients with IBS. The ultimate clinical effects depend primarily on probiotic strain selection. Our research team evaluated a multi-strain probiotic formulation and a multi-strain synbiotic (a combination of probiotic strains with short-chain prebiotic fructooligosaccharides) formulation as part of two randomized placebo-controlled clinical trials in patients with IBS with predominant diarrhea. The results indicated a beneficial effect of these formulations on the clinical course of IBS assessed with the international IBS symptom severity scale (IBS-SSS), with each of the study formulations exhibiting efficacy in different fields. The formulation composed of a mixture of Bifidobacterium and Lactobacillus strains reduced the levels of pain and improved the quality of life, whereas the synbiotic formulation effectively improved bloating and had a beneficial effect on the general condition of the intestines. A systematic review and meta-analysis published in 2020 showed that high doses of single-strain formulations, particularly those containing Bifidobacterium or Lactobacillus strains, may be more effective in IBS patients. Other reports demonstrated a high efficacy of the new-generation probiotic Bacillus coagulans in IBS. Therefore, the main objective of this research project is to assess the efficacy of single-strain probiotics containing Bifidobacterium lactis or Bacillus coagulans in patients with IBS.
Detailed description
This is a randomized double-blind placebo-controlled trial included 120 adult patients, who had been diagnosed with IBS according to the Rome IV diagnostic criteria. The patients will receive orally a probiotic formulation containing Bifidobacterium lactis or Bacillus coagulans or placebo over a period of 12 weeks. Once the period of supplementation is completed, the patients will be followed-up for the subsequent 4 weeks. The patients included in the study will receive diaries, which they will complete daily. The patient's dairy will include information about the number of stools, stool consistency (assessed based on the Bristol Stool Form Scale) and IBS symptoms (abdominal pain, bloating, bowel urgency, and feeling of incomplete evacuation) rated in a 5-grade scale. The diary will also include information on any adverse events and the use of any new medications during the study. Once a week, the patients will be contacted by phone by interviewers who will collect the information recorded in the patient's diary.
During the first visit, the patients included in the study will be informed of the study procedure and educated on the phone exchanges with the interviewers. One week prior to study intervention, the patients will be asked to record their symptoms in their patient diaries every day. Subsequently, the patients will visit their study doctor every four weeks (from the beginning of the study intervention) in order to receive the next dose of the study formulation/placebo. During each study visit, the patients will be evaluated with the use of IBS-SSS and IBS Global Improvement Scale (IBS-GIS). The patients included in the study will undergo a hydrogen breath test for small intestinal bacterial overgrowth (SIBO) both prior to receiving the study formulation/placebo and 12 weeks later, after intervention is completed.
The study will last a total of 16 weeks from the moment the intervention is initiated (12 weeks of interventions and 4 weeks of follow-up).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bifidobacterium lactis | Active comparator | Dietary Supplement: Probiotic Bifidobacterium lactisProbiotic formula contains 5x109 Bifidobacterium lactis Nordbiotic™ BI040 colony forming units (CFU)/capsule |
| Bacillus coagulans | Active comparator | Dietary Supplement: Probiotic Bacillus coagulansProbiotic formula contains 2x109 Bacillus coagulans Nordbiotic™BC300 colony forming units (CFU)/capsule |
| Maltodextrin | Placebo comparator | Dietary Supplement: PlaceboMaltodextrin (starch hydrolisate) as a compound presents in probiotic formula. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Caucasian males and females;
- Age from 18 to 70 years, inclusive;
- Good physical and mental condition assessed based on the patient's history and physical examination;
- Laboratory test results (blood tests, including blood chemistry and antibody tests; and urinalysis) within the normal limits for the local laboratory or considered clinically insignificant by the study investigator;
- A voluntarily provided written informed consent;
Key exclusion criteria (18 listed)
- Cardiovascular disorders: uncontrolled hypertension (blood pressure > 170/100 mmHg), cerebrovascular disease;
- Severe respiratory disorders (asthma, chronic obstructive pulmonary disease)
- Liver or kidney disease and unexplained blood chemistry abnormalities: serum creatinine of more than twice the upper limit of normal, serum aminotransferease (AST or ALT) levels more than twice the upper limit of normal;
- Gastrointestinal disorders other than IBS (including gastroenteritis, celiac disease, and bacterial infections or parasitic infestations confirmed either clinically or endoscopically);
- Endocrine disorders, including diabetes (fasting blood glucose > 11 mmol/L) and serum thyroid stimulating hormone (TSH) levels above normal;
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 Bifidobacterium lactisThe probiotic will be administered orally over a period of 12 weeks. | Dietary supplement | Bifidobacterium lactis |
| Probiotic Bacillus coagulansThe probiotic will be administered orally over a period of 12 weeks. | Dietary supplement | Bacillus coagulans |
| PlaceboMaltodextrin as a placebo will be administered orally over a period of 12 weeks. The taste and appearance of the placebo will be similar to those of the probiotic formulation. | Dietary supplement | Maltodextrin |
Primary outcome
Changes in severity of IBS symptoms using IBS Severity Scoring System (IBS-SSS)
Time frame: From baseline at 4, 8, 12 weeks of intervention, and 4 weeks (16 weeks of the study) after intervention
IBS-SSS is a 5-question survey that asks: 1. the severity of abdominal pain, 2. frequency of abdominal pain, 3. severity of abdominal distention, 4.dissatisfaction with bowel habit, and 5. interference with quality of life over the past 10 days. Subjects respond to each question on a 100-point visual analogue scale. Each of the five question generates a maximum score of 100 point, and total scores can range from 0-500 with higher scores indicating severe symptoms. A decrease of 50 points is associated with a clinically meaningful improvement.
Improvement of IBS global symptoms using Global Improvement Scale (IBS-GIS)
Time frame: From baseline at 4, 8, 12 weeks of intervention, and 4 weeks (16 weeks of the study) after intervention
IBS-Global Improvement Scale assesses IBS symptoms using a patient-defined 7 point Likert scale ranging from symptoms substantially worse to substantially improved. Patients answer the question "Have you felt any change in the severity of your symptoms over the past 7 days compared to how you felt before the medicine was given? The answers are recorded based on the 7-point scale: 1. = I feel that the symptoms have worsened significantly 2. = I feel that the symptoms have moderately worsened 3. = I feel that the symptoms have slightly worsened 4. = I feel no change 5. = I feel a slight improvement 6. = I feel moderate improvement 7. = I feel significant improvement IBS-GIS score indicates: improvement if is >4 or worsening if is<4, no change if is 4
5 secondary outcomes
Changes in number of stools
Time frame: From baseline for 12 weeks of intervention, and for 4 weeks after intervention
Changes in severity of pain
Time frame: From baseline for 12 weeks of intervention, and for 4 weeks after intervention
Changes in flatulence
Time frame: From baseline for 12 weeks of intervention, and for 4 weeks after intervention
Occurrence of side effects
Time frame: From baseline for 12 weeks of intervention
Changes in type of stools
Time frame: From baseline for 12 weeks of intervention, and for 4 weeks after intervention
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 7 Jul 2023.
- Derived from this study: PubMed 37510953Skrzydlo-Radomanska B, Prozorow-Krol B, Kurzeja-Miroslaw A, Cichoz-Lach H, Laskowska K, Majsiak E, Bierla JB, Agnieszka S, Cukrowska B. The Efficacy and Safety of Single-Strain Probiotic Formulations Containing Bifidobacterium lactis or Bacillus coagulans in Adult Patients with Irritable Bowel Syndrome-A Randomized Double-Blind Placebo-Controlled Three-Arm Interventional Trial. J Clin Med. 2023 Jul 22;12(14):4838. doi: 10.3390/jcm12144838.
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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.
Barbara Skrzydło-Radomańska, MD, PhD principal investigator
Medical University of Lublin
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 Bifidobacterium lactis and Probiotic Bacillus coagulans in people with Irritable Bowel Syndrome, run by Nordic Biotic Sp. z o.o. at 1 site in Poland.
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 8 inclusion and 18 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 7 Jul 2023. 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 Poland. 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?
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?
Changes in severity of IBS symptoms using IBS Severity Scoring System (IBS-SSS) (time frame: From baseline at 4, 8, 12 weeks of intervention, and 4 weeks (16 weeks of the study) after intervention). The study lists 2 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 NCT05064930, which also lists 1 linked publication.
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 7 Jul 2023.