Diarrhoea of Diverse Aetiology Requiring Oral Rehydration TherapyABB S3/ABB C22NCT06738420

Medical Nutrition Formulations Enriched With Postbiotics for the Management of Gastrointestinal Disorders

A study testing ABB S3 and ABB C22 in people with Diarrhoea of Diverse Aetiology Requiring Oral Rehydration Therapy and Diarrhoea and Gastrointestinal Symptoms Secondary to Enteral Nutrition, run by AB Biotek at 1 site in Spain.

Completed

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

Official record

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Trial summary

Efficacy and tolerability of ABB i5 prebiotic and ABB C22 postbiotics for the management of constipation and gastrointestinal well-being: a pilot trial Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Diarrhoea of Diverse Aetiology Requiring Oral Rehydration Therapy, Diarrhoea and Gastrointestinal Symptoms Secondary to Enteral Nutrition
What is being tested?: ABB S3 and ABB C22
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 100 participants
Where: 1 siteSpain
Study dates: 27 Jan 2023to 4 Apr 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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Inpatients of the centre
Diagnostic of diarrhoea: increase in daily faecal weight > 200 g (as per the Centre protocol).
Subjects who as per the Centre protocol require Oral rehydration therapy
Patients with the ability to take the study product orally

Who cannot join

History of allergy, idiosyncrasy, hypersensitivity or adverse reactions to the active principle or to any of the excipients.
History or evidence of any medical conditions or medication used that, in the opinion of the principal investigator, could affect the safety of the subjects or interfere with the study evaluations
Patients in situation of last days
Amytriptilin and masalazine treatment (anti-depressives)
Laxatives

Trial locations and contacts

1 site in 1 country.

Spain1 site

Isabel Roig
Barcelona, Barcelona, 0803'

Other trials in Spain

About this study

Official title: Efficacy and Tolerability of a Nutritional Supplementation With Medical Nutrition Formulations Enriched With Postbiotics for the Management of Gastrointestinal Disorders: a Pilot Trial

Efficacy and tolerability of ABB i5 prebiotic and ABB C22 postbiotics for the management of constipation and gastrointestinal well-being: a pilot trial

Conditions: Diarrhoea of Diverse Aetiology Requiring Oral Rehydration Therapy, Diarrhoea and Gastrointestinal Symptoms Secondary to Enteral Nutrition
Being tested: ABB S3, ABB C22, Placebo
Keywords: diarrhoea, postbiotic, adults
Medical subject headings: Diarrhea

What participants receive

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

ABB S3Dietary supplement
Postbiotic ABB S3 for suspension into Nutritional supplementation with Medical Nutrition Formula for the management of gastrointestinal symptoms secondary to enteral nutrition
ABB C22Dietary supplement
Oral Rehydration Solution containing postbiotics ABB C22 for the management of diarrhoea signs of dehydration
PlaceboDietary supplement
Placebo for suspension into Nutritional supplementation with Medical Nutrition Formula for the management of gastrointestinal symptoms secondary to enteral nutrition
PlaceboDietary supplement
Oral Rehydration Solution containing placebo for the management of diarrhoea signs of dehydration

Study groups in NCT06738420
Study group	Role	What they receive
ABB S3 - active	Experimental	Postbiotic ABB S3 for suspension into Nutritional supplementation with Medical Nutrition Formula for the management of gastrointestinal symptoms secondary to enteral nutrition Receives: Dietary Supplement: ABB S3
ABB S3 - Placebo	Placebo comparator	Placebo for suspension into Nutritional supplementation with Medical Nutrition Formula for the management of gastrointestinal symptoms secondary to enteral nutrition Receives: Dietary Supplement: Placebo
ABB C22 - active	Experimental	Oral Rehydration Solution containing postbiotics ABB C22 for the management of diarrhoea signs of dehydration Receives: Dietary Supplement: ABB C22
ABB C22 - placebo	Placebo comparator	Oral Rehydration Solution containing placebo for the management of diarrhoea signs of dehydration Receives: Dietary Supplement: Placebo

What is being measured

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

Faecal calprotectin
change in faecal calprotectin levels (mg/g)
Measured: from baseline to day 14 of supplementation
faecal lactoferrin
change in the number of participants with a positive "faecal lactoferrin" result (%)
Measured: from baseline to day 14 of supplementation
Blood IgAs
levels of serum IgAs (mg/dL)
Measured: from baseline to day 14 of supplementation

Secondary outcomes (2)

Gastrointestinal symptoms
assessment of number of diarrhea, vomits and regurgitation events
Measured: from baseline to day 14 of supplementation
faecal consisitency
assessed through Bristol scale (1-7 score)
Measured: from baseline to day 14 of supplementation

Timeline

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

27 Jan 20234 Apr 2024

First posted17 Dec 2024
Study start27 Jan 2023
Primary completion6 Mar 2024
Study completion4 Apr 2024

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 Diarrhoea of Diverse Aetiology Requiring Oral Rehydration TherapyStudies 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: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06738420
Sponsor's protocol ID: 2022-003423-18
Acronym: ABB S3/ABB C22
Status last verified: Oct 2025
First submitted: 13 Dec 2024
Last updated: 7 Oct 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Biomarkers data (calprotectin, lactoferrin, igA) data, Bristol scale data

Publications

Mateus Rodriguez JA, Rodriguez Sanz P, Kostandyan E, Palacios Sanchez R, Pino Roque ML, Chaves Vasquez P, Roy Millan P. Mitigating Diarrhoea-Related Inflammation in Frail Older Adults with Postbiotic-Enhanced Oral Rehydration Solution: Insights from a Randomised, Double-Blind, Placebo-Controlled Study. Geriatrics (Basel). 2025 Mar 1;10(2):34. doi: 10.3390/geriatrics10020034.
PubMed 40126284

Study at a glance

From the registry record, last updated by the sponsor on 7 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy and Tolerability of a Nutritional Supplementation With Medical Nutrition Formulations Enriched With Postbiotics for the Management of Gastrointestinal Disorders: a Pilot Trial
ClinicalTrials.gov ID: NCT06738420
Acronym / sponsor ID: ABB S3/ABB C22 / 2022-003423-18
Conditions: Diarrhoea of Diverse Aetiology Requiring Oral Rehydration Therapy, Diarrhoea and Gastrointestinal Symptoms Secondary to Enteral Nutrition
Keywords: diarrhoea, postbiotic, adults
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: AB BiotekIndustry (pharma, biotech, devices)
Collaborators: Colisée Barcelona Isabel Roig, Grupo Colisée
Study start: 27 Jan 2023 (actual)
Primary completion: 6 Mar 2024 (actual)
Study completion: 4 Apr 2024 (actual)
First posted: 17 Dec 2024 (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.

Efficacy and tolerability of ABB i5 prebiotic and ABB C22 postbiotics for the management of constipation and gastrointestinal well-being: a pilot trial

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
ABB S3 - active	Experimental	Dietary Supplement: ABB S3Postbiotic ABB S3 for suspension into Nutritional supplementation with Medical Nutrition Formula for the management of gastrointestinal symptoms secondary to enteral nutrition
ABB S3 - Placebo	Placebo comparator	Dietary Supplement: PlaceboPlacebo for suspension into Nutritional supplementation with Medical Nutrition Formula for the management of gastrointestinal symptoms secondary to enteral nutrition
ABB C22 - active	Experimental	Dietary Supplement: ABB C22Oral Rehydration Solution containing postbiotics ABB C22 for the management of diarrhoea signs of dehydration
ABB C22 - placebo	Placebo comparator	Dietary Supplement: PlaceboOral Rehydration Solution containing placebo for the management of diarrhoea signs of dehydration

Who may qualify

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

Key inclusion criteria (4 listed)

Inpatients of the centre

Key exclusion criteria (5 listed)

History of allergy, idiosyncrasy, hypersensitivity or adverse reactions to the active principle or to any of the excipients.

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
ABB S3Postbiotic ABB S3 for suspension into Nutritional supplementation with Medical Nutrition Formula for the management of gastrointestinal symptoms secondary to enteral nutrition	Dietary supplement	ABB S3 - active
ABB C22Oral Rehydration Solution containing postbiotics ABB C22 for the management of diarrhoea signs of dehydration	Dietary supplement	ABB C22 - active
PlaceboPlacebo for suspension into Nutritional supplementation with Medical Nutrition Formula for the management of gastrointestinal symptoms secondary to enteral nutrition	Dietary supplement	ABB S3 - Placebo
PlaceboOral Rehydration Solution containing placebo for the management of diarrhoea signs of dehydration	Dietary supplement	ABB C22 - placebo

Primary outcome

Faecal calprotectin
Time frame: from baseline to day 14 of supplementation
change in faecal calprotectin levels (mg/g)
faecal lactoferrin
Time frame: from baseline to day 14 of supplementation
change in the number of participants with a positive "faecal lactoferrin" result (%)
Blood IgAs
Time frame: from baseline to day 14 of supplementation
levels of serum IgAs (mg/dL)

2 secondary outcomes

Gastrointestinal symptoms
Time frame: from baseline to day 14 of supplementation
faecal consisitency
Time frame: from baseline to day 14 of supplementation

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 Oct 2025.
Derived from this study: PubMed 40126284Mateus Rodriguez JA, Rodriguez Sanz P, Kostandyan E, Palacios Sanchez R, Pino Roque ML, Chaves Vasquez P, Roy Millan P. Mitigating Diarrhoea-Related Inflammation in Frail Older Adults with Postbiotic-Enhanced Oral Rehydration Solution: Insights from a Randomised, Double-Blind, Placebo-Controlled Study. Geriatrics (Basel). 2025 Mar 1;10(2):34. doi: 10.3390/geriatrics10020034.
Individual participant dataSharing planned: Yes. Biomarkers data (calprotectin, lactoferrin, igA) data, Bristol scale data

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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Oct 2025. 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 Spain. 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?

Faecal calprotectin (time frame: from baseline to day 14 of supplementation). The study lists 3 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 NCT06738420, 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 Oct 2025.