Chronic Diarrhoea of Infants and/or Young ChildrenNCT05904938
Oral Administration of Actitan-F in Paediatric Diarrhoea
A study testing Lenodiar Pediatric in people with Chronic Diarrhoea of Infants and/or Young Children, run by Aboca Spa Societa' Agricola at 12 sites in Italy.
Trial summary
The goal of the study is to investigate the efficacy and safety of Lenodiar Pediatric (product under investigation) for the treatment of Chronic Diarrhoea (functional or post-infective diarrhoea) in children aged 1-5 years old, through a randomized, double blind, placebo-controlled clinical investigation Read more about this study
- Who is it for?
- Ages 1 year to 5 years
- Conditions the study is for
- Chronic Diarrhoea of Infants and/or Young Children
- What is being tested?
- Lenodiar Pediatric
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 136 participants
- Where
- 12 sitesItaly
- Study dates
- 10 Jul 2023to 31 Dec 2024
- 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 1 year to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children of either sex aged between 1-5 years (inclusive);
- Diagnosis of chronic diarrhoea due to the following conditions:
- Functional gastrointestinal disorder fulfilling Rome IV Criteria*
- or
- Functional gastrointestinal disorder fulfilling modified Rome IV Criteria **
- or
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- Post-infectious diarrea with daily painless, recurrent passage of three or more large, unformed stools
- Parents/legal guardians*** availability to fill on a daily basis the electronic daily diary by a smartphone/tablet.
- Parents/legal guardians have given a written informed consent for participation in the investigation at the time of enrolment or before. The parent/legal guardian should also have agreed to bring the child for the visits scheduled in the protocol and to provide the requested information during the telephonic follow-up visit;
- Parents/legal guardian able to understand the full nature and the purpose of the investigation, including possible risks and side effects, able to cooperate with the Investigator and to comply with the requirements of the entire investigation (ability to attend all the planned investigation visits according to the time limits included) based on Investigator's judgement;
- Willingness not to make diet and lifestyle significant changes during the trial.
- Rome IV criteria of functional diarrhoea (Neonate and Toddlers below 5 years), must include all of the following:
- Daily painless, recurrent passage of four or more large, unformed stools
- Symptoms last more than 4 weeks
- Onset between 6 and 60 months of age
- No failure-to-thrive if caloric intake is adequate
- Modified Rome IV criteria of functional diarrhoea (Neonate and Toddlers below 5 years), must include all of the following:
- Daily painless, recurrent passage of three or more large, unformed stools
- Symptoms last more than 2 weeks (Nelson Pediatric Texbook 21st Edition, Chronic diarrhea)
- Onset between 6 and 60 months of age
- No failure-to-thrive if caloric intake is adequate
- These criteria have been modified in order to align the study to the functional diarrhoea condition in the real life.
- Parent is the child's biological or adoptive parent. Legal guardian is defined as an individual who was authorized under applicable state or local law to consent on behalf of a child to general medical care, when general medical care includes participation in research. A guardian also meant an individual who was authorized to consent on behalf of a child to participate in research.
Who cannot join
- Carbohydrate malabsorption, diagnosed either clinically (2 weeks exclusion diet with resolution of symptoms) or with proper testing (breath test)*;
- Patients with any of the following chronic gastrointestinal disorders: inflammatory bowel disease, pancreatitis, chronic liver disease, eosinophilic oesophagitis, peptic ulcer disease, celiac disease, pseudo-obstruction, small bowel bacterial overgrowth, or Hirschsprung's disease
- Significant chronic health condition requiring specialty care (e.g., lithiasis, ureteropelvic junction obstruction, sickle cell, cerebral palsy, hepatic, hematopoietic, renal, endocrine, or metabolic diseases) that could potentially impact the child's ability to participate or confound the results of the investigation;
- Gastrointestinal blood loss;
- Recurrent or unexplained fevers;
- Developmental disabilities impairing ability to understand or communicate;
Show all 21Show fewer
- History of hypersensitivity or allergy to investigational product;
- History of previous abdominal surgeries in the past 3 months;
- Known hypersensitivity to any of the components (active ingredients or excipients) of the investigational product;
- Conditions known to producing immunodeficiency (AIDS, other congenital immunodeficiency syndromes, drugs therapy with steroids, anticancer drugs, etc.);
- Patients who have received any of the following treatments within the 2 weeks before the baseline visit:
- Agents specially developed for achieving adsorbing properties, e.g. kaolin, pectin, bismuth subsalicylate;
- Treatments that modify intestinal secretions, e.g. racecadotril;
- Treatments that modify intestinal motility, e.g. opiates, anti-cholinergic agents;
- Systemic Antibiotics;
- Antiemetic agents.
- Patients who have received probiotics and prebiotics within the 1 week before the baseline visit, unless they have been taken at stable dose (the use of probiotics and prebiotics in dairy food such as yoghurt, cheese, milk prior to the investigation is permitted);
- Parents/legal guardians' refusal or inability to give written informed consent to participate in the investigation;
- Parents/legal guardians who, in the opinion of the Investigator, are unable to fill up the electronic patient diary;
- Patients who have participated in any other clinical trial in the last 3 months prior to the start of the investigation.
- Applicable only for patients with Functional gastrointestinal disorder fulfilling Rome IV Criteria.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Italy12 sites, 12 recruiting
- Recruiting
ASST Papa Giovanni XXIII
Bergamo
Naire Sansotta, Dr
- Recruiting
Azienda Ospedaliera Cannizzaro, UOC Pediatria e PS Pediatrico
Catania, 95126
Antonella Di Stefano, Professor, +39957264334, vitantonelladistefano@gmail.com
- Recruiting
Policlinico "SS. Annunziata" Clinica Pediatrica Via dei Vestini, Località colle dell'Ara 66100, Chieti
Chieti
Francesco Chiarelli, Professor, chiarelli@unich.it
- Recruiting
IRCCS AOU Meyer SOC Gastroenterologia e Nutrizione, Viale Gaetano Pieraccini 24
Florence, 50139
Paolo Lionetti, Professor, paolo.lionetti@unifi.it
- Recruiting
Azienda Socio Sanitaria Territoriale Santi Paolo e Carlo Presidio San Carlo, Ambulatorio di Gastroenterologia Pediatrica
Milan, 20135
Diana Ghisleni, Professor, +02/8184.4171, diana.ghisleni@asst-santipaolocarlo.it
- Recruiting
Azienda Ospedaliera Universitaria "Federico II",
Naples, Italia, 80131
Annamaria Staiano, Professor, +39817462679, staiano@unina.it
- Recruiting
Azienda Ospedaliera Universitaria- Università degli Studi della Campania "Luigi Vanvitelli", I Clinica Pediatrica
Naples, 80138
Caterina Strisciuglio, Professor, 081 566 5445, caterina.strisciuglio@unicampania.it
- Not yet recruiting
ARNAS Ospedale Civico e Benfratelli G Cristina e M Ascoli, Pediatria ad Indirizzo Gastroenterologico
Palermo, 90134
Francesca Cavataio, Professor, +39916666197, francesca.cavataio@arnascivico.it
- Recruiting
Fondazione IRCCS Policlinico San Matteo, Pediatria
Pavia, 27100
Silvia Maria Elena Caimmi, Professor, +390382502923, gl.marseglia@smatteo.pv.it
- Not yet recruiting
Ospedale S. Maria della Misericordia
Perugia
Rita Cozzali, Dr
- Recruiting
Ospedale San Jacopo di Pistoia, SOC Pediatria
Pistoia, 51100
Rino Agostiniani, Professor, +39573367379, rinoagostiniani@gmail.com
- Not yet recruiting
U.O. di Gastroenterologia e Riabilitazione Nutrizionale Ospedale Pediatrico Bambin Gesu Piazza S. Onofrio, 4 00165, Roma
Roma
Antonella Diamanti, Professor, antonella.diamanti@opbg.net
About this study
Official title: Efficacy and Safety of Oral Administration of the Plant-based Complex Actitan-F in the Management of Chronic Paediatric Diarrhoea: a Double-blind, Placebo-controlled, Parallel-group Investigation
The goal of the study is to investigate the efficacy and safety of Lenodiar Pediatric (product under investigation) for the treatment of Chronic Diarrhoea (functional or post-infective diarrhoea) in children aged 1-5 years old, through a randomized, double blind, placebo-controlled clinical investigation
- Being tested
- Lenodiar Pediatric, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lenodiar PediatricDevice
Medical Device made of natural substance
PlaceboOther
Product appearance similar to verum without clinical efficacy
| Study group | Role | What they receive |
|---|---|---|
| Lenodiar Pediatric | Experimental | Medical Device Receives: Device: Lenodiar Pediatric |
| Placebo | Placebo comparator | Placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in stool consistency averaged over the 2-week Treatment Period
Stool consistency will be assessed using the Bristol Stool Form Scale (BSFS) on a range from 1 (Hard Lumps) to 7 (Watery).
Measured: Up to 2 weeks vs Baseline
Secondary outcomes (26)
Change for daily daytime and nighttime stool consistency scores
Change for daily daytime and nighttime stool consistency scores assessed using the Bristol Stool Form Scale (BSFS) on a range from 1 (Hard Lumps) to 7 (Watery).
Measured: (Week1 to Week4) vs Baseline
Change for 24-hour abdominal pain scores
Abdominal Pain is scored on a five-point ordinal scale, with 0 meaning no pain, and 4 meaning a lot of pain.
Measured: (Week1 to Week4) vs Baseline
Change for daytime, nighttime, and 24-hour bowel movement frequency
Change for daytime, nighttime, and 24-hour bowel movement frequency
Measured: (Week1 to Week4) vs Baseline
Change for daytime, nighttime, and 24-hour urgency-free days
Change for daytime, nighttime, and 24-hour urgency-free days (only for patients who have removed the diaper and have received training toilet)
Measured: (Week1 to Week4) vs Baseline
Time to event, with the event defined as the first week in which a reduction ≥50% of loose or watery stools as compared to baseline occurs.
Time to event is defined as the time elapsed (days) from the date of randomization to the date of the first week in which a reduction ≥50% of loose or watery stools as compared to baseline occurs. This endpoint will be assessed through electronic diary.
Measured: through study completion, an average of 4 weeks
Use of other treatments (proportion of users) for diarrhea relief, evaluated by means of the electronic patient diaries;
Use of other treatments (proportion of users and quantity) for diarrhea relief, evaluated through a electronic patient diaries;
Measured: through study completion, an average of 4 weeks
Use of other treatments (quantity of other treatments) for diarrhea relief, evaluated by means of the electronic patient diaries;
Use of other treatments (proportion of users and quantity) for diarrhea relief, evaluated through a electronic patient diaries;
Measured: through study completion, an average of 4 weeks
Change in results of the Pediatric Quality of Life Questionnaires
Change in results of the Pediatric Quality of Life Questionnaires assessed through a validated questionnaire
Measured: Visit 1 (day 14); Visit 2 (day 28);
Change in results of the patient happiness using a weekly smiley likert scale
Parents/legal guardians will report, on a weekly basis, the happiness of the patients using a smiley face likert scale (Very happy; Happy; Slightly happy; Neutral; Slightly unhappy)
Measured: through study completion, an average of 4 weeks
Change in results in parent Quality of Life (100 mm VAS)
Change in results in parent Quality of Life using a 100 mm Visual Analogie Scale, ranging from "0" (corresponds to a quality of life "very low") and the value "100" (corresponds to a quality of life "very high")
Measured: Baseline to Visit 1 (day 14) and Visit 2 (day 28) and Visit 1 (day 14) to Visit 2 (day 28)
Time to event, with the event defined as the first day in which loose or watery stools are not observed.
Time to event is defined as the time elapsed (days) from the date of randomization to the date of the first day in which loose or watery stools are not observed.
Measured: through study completion, an average of 4 weeks
Change in patients' lifestyle
Change in patients' lifestyle assessed through a lifestyle questionnaire
Measured: Baseline to Visit 1 (day 14) and Visit 2 (day 28) and Visit 1 (day 14) to Visit 2 (day 28)
Time to event, with the event defined as the third day of the first consecutive three days in which diagnostic criteria for chronic diarrhoea are no more met.
Time to event is defined as the time elapsed (days) from the date of randomization to the date of the third of the first consecutive three days in which diagnostic criteria for chronic diarrhoea are no more met
Measured: through study completion, an average of 4 weeks
Change from baseline in stool consistency at day 3, day 7 and day 10.
Change from baseline in stool consistency at day 3, day 7 and day 10. Stool consistency will be assessed using the Bristol Stool Form Scale (BSFS) on a range from 1 (Hard Lumps) to 7 (Watery).
Measured: Baseline to day 3, day 7 and day 10
Adverse Event
Incidence of adverse events (AEs)
Measured: through study completion, an average of 4 weeks
Serious Adverse Event
Incidence of serious adverse events (SAEs)
Measured: through study completion, an average of 4 weeks
Adverse device effects
Incidence of adverse device effects (ADEs)
Measured: through study completion, an average of 4 weeks
Serious adverse device effects
Incidence of a serious adverse device effects (SADEs)
Measured: through study completion, an average of 4 weeks
Unexpected serious adverse device effects
Incidence of unexpected serious adverse device effects (USADEs)
Measured: through study completion, an average of 4 weeks
Early withdrawal rate due to AEs
Incidence of early withdrawal rate due to AEs, whether serious or not
Measured: through study completion, an average of 4 weeks
Safety Endpoints - early withdrawal rate due to ADEs
Incidence of early withdrawal rate due to ADEs, whether serious or not.
Measured: through study completion, an average of 4 weeks
Systolic/diastolic blood pressure
Change from baseline in clinical examination findings (systolic/diastolic blood pressure)
Measured: Baseline to Visit 1 (day 14) and Visit 2 (day 28) and Visit 1 (day 14) to Visit 2 (day 28)
Pulse
Change from baseline in clinical examination findings (pulse)
Measured: Baseline to Visit 1 (day 14) and Visit 2 (day 28) and Visit 1 (day 14) to Visit 2 (day 28)
Weight
Change from baseline in clinical examination findings (weight)
Measured: Baseline to Visit 1 (day 14) and Visit 2 (day 28) and Visit 1 (day 14) to Visit 2 (day 28)
Body Mass Index
Change from baseline in clinical examination findings (Body Mass Index)
Measured: Baseline to Visit 1 (day 14) and Visit 2 (day 28) and Visit 1 (day 14) to Visit 2 (day 28)
Waist circumference
Change from baseline in clinical examination findings (waist circumference)
Measured: Baseline to Visit 1 (day 14) and Visit 2 (day 28) and Visit 1 (day 14) to Visit 2 (day 28)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start10 Jul 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Diarrhoea of Infants and/or Young ChildrenStudies 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
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aboca Spa Societa' Agricola
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- IQVIA RDS Inc., IQVIA Pty Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05904938
- Sponsor's protocol ID
- ABO-LENP-01/22
- Status last verified
- Jun 2023
- First submitted
- 16 Mar 2023
- Last updated
- 7 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Oral Administration of the Plant-based Complex Actitan-F in the Management of Chronic Paediatric Diarrhoea: a Double-blind, Placebo-controlled, Parallel-group Investigation
- ClinicalTrials.gov ID
- NCT05904938
- Acronym / sponsor ID
- ABO-LENP-01/22
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- Aboca Spa Societa' AgricolaIndustry (pharma, biotech, devices)
- Collaborators
- IQVIA RDS Inc., IQVIA Pty Ltd
- Study start
- 10 Jul 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 15 Jun 2023 (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.
The goal of the study is to investigate the efficacy and safety of Lenodiar Pediatric (product under investigation) for the treatment of Chronic Diarrhoea (functional or post-infective diarrhoea) in children aged 1-5 years old, through a randomized, double blind, placebo-controlled clinical investigation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lenodiar Pediatric | Experimental | Device: Lenodiar PediatricMedical Device |
| Placebo | Placebo comparator | Other: PlaceboPlacebo |
Who may qualify
- Ages
- 1 year to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (23 listed)
- Children of either sex aged between 1-5 years (inclusive);
- Diagnosis of chronic diarrhoea due to the following conditions:
- Parents/legal guardians*** availability to fill on a daily basis the electronic daily diary by a smartphone/tablet.
- Parents/legal guardians have given a written informed consent for participation in the investigation at the time of enrolment or before. The parent/legal guardian should also have agreed to bring the child for the visits scheduled in the protocol and to provide the requested information during the telephonic follow-up visit;
- Parents/legal guardian able to understand the full nature and the purpose of the investigation, including possible risks and side effects, able to cooperate with the Investigator and to comply with the requirements of the entire investigation (ability to attend all the planned investigation visits according to the time limits included) based on Investigator's judgement;
Key exclusion criteria (21 listed)
- Carbohydrate malabsorption, diagnosed either clinically (2 weeks exclusion diet with resolution of symptoms) or with proper testing (breath test)*;
- Patients with any of the following chronic gastrointestinal disorders: inflammatory bowel disease, pancreatitis, chronic liver disease, eosinophilic oesophagitis, peptic ulcer disease, celiac disease, pseudo-obstruction, small bowel bacterial overgrowth, or Hirschsprung's disease
- Significant chronic health condition requiring specialty care (e.g., lithiasis, ureteropelvic junction obstruction, sickle cell, cerebral palsy, hepatic, hematopoietic, renal, endocrine, or metabolic diseases) that could potentially impact the child's ability to participate or confound the results of the investigation;
- Gastrointestinal blood loss;
- Recurrent or unexplained fevers;
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 |
|---|---|---|
| Lenodiar PediatricMedical Device made of natural substance | Device | Lenodiar Pediatric |
| PlaceboProduct appearance similar to verum without clinical efficacy | Other | Placebo |
Primary outcome
Change from baseline in stool consistency averaged over the 2-week Treatment Period
Time frame: Up to 2 weeks vs Baseline
Stool consistency will be assessed using the Bristol Stool Form Scale (BSFS) on a range from 1 (Hard Lumps) to 7 (Watery).
26 secondary outcomes
Change for daily daytime and nighttime stool consistency scores
Time frame: (Week1 to Week4) vs Baseline
Change for 24-hour abdominal pain scores
Time frame: (Week1 to Week4) vs Baseline
Change for daytime, nighttime, and 24-hour bowel movement frequency
Time frame: (Week1 to Week4) vs Baseline
Change for daytime, nighttime, and 24-hour urgency-free days
Time frame: (Week1 to Week4) vs Baseline
Time to event, with the event defined as the first week in which a reduction ≥50% of loose or watery stools as compared to baseline occurs.
Time frame: through study completion, an average of 4 weeks
Use of other treatments (proportion of users) for diarrhea relief, evaluated by means of the electronic patient diaries;
Time frame: through study completion, an average of 4 weeks
Use of other treatments (quantity of other treatments) for diarrhea relief, evaluated by means of the electronic patient diaries;
Time frame: through study completion, an average of 4 weeks
Change in results of the Pediatric Quality of Life Questionnaires
Time frame: Visit 1 (day 14); Visit 2 (day 28);
Change in results of the patient happiness using a weekly smiley likert scale
Time frame: through study completion, an average of 4 weeks
Change in results in parent Quality of Life (100 mm VAS)
Time frame: Baseline to Visit 1 (day 14) and Visit 2 (day 28) and Visit 1 (day 14) to Visit 2 (day 28)
Time to event, with the event defined as the first day in which loose or watery stools are not observed.
Time frame: through study completion, an average of 4 weeks
Change in patients' lifestyle
Time frame: Baseline to Visit 1 (day 14) and Visit 2 (day 28) and Visit 1 (day 14) to Visit 2 (day 28)
Time to event, with the event defined as the third day of the first consecutive three days in which diagnostic criteria for chronic diarrhoea are no more met.
Time frame: through study completion, an average of 4 weeks
Change from baseline in stool consistency at day 3, day 7 and day 10.
Time frame: Baseline to day 3, day 7 and day 10
Adverse Event
Time frame: through study completion, an average of 4 weeks
Serious Adverse Event
Time frame: through study completion, an average of 4 weeks
Adverse device effects
Time frame: through study completion, an average of 4 weeks
Serious adverse device effects
Time frame: through study completion, an average of 4 weeks
Unexpected serious adverse device effects
Time frame: through study completion, an average of 4 weeks
Early withdrawal rate due to AEs
Time frame: through study completion, an average of 4 weeks
Safety Endpoints - early withdrawal rate due to ADEs
Time frame: through study completion, an average of 4 weeks
Systolic/diastolic blood pressure
Time frame: Baseline to Visit 1 (day 14) and Visit 2 (day 28) and Visit 1 (day 14) to Visit 2 (day 28)
Pulse
Time frame: Baseline to Visit 1 (day 14) and Visit 2 (day 28) and Visit 1 (day 14) to Visit 2 (day 28)
Weight
Time frame: Baseline to Visit 1 (day 14) and Visit 2 (day 28) and Visit 1 (day 14) to Visit 2 (day 28)
Body Mass Index
Time frame: Baseline to Visit 1 (day 14) and Visit 2 (day 28) and Visit 1 (day 14) to Visit 2 (day 28)
Waist circumference
Time frame: Baseline to Visit 1 (day 14) and Visit 2 (day 28) and Visit 1 (day 14) to Visit 2 (day 28)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2024.
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.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lenodiar Pediatric in people with Chronic Diarrhoea of Infants and/or Young Children, run by Aboca Spa Societa' Agricola at 12 sites in Italy.
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 23 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luca Franceschini, Ph. D (+39 3386794491, lfranceschini@aboca.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in stool consistency averaged over the 2-week Treatment Period (time frame: Up to 2 weeks vs Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 May 2024.