ConstipationEarly Phase 1ABB i5/ABB C24NCT06738433
Efficacy and Tolerability of ABB I5 Prebiotic and ABB C22 Postbiotics for the Management of Constipation and Gastrointestinal Well-being: a Pilot Trial
A Early Phase 1 study testing ABB i5 and ABB C24 in people with Constipation, run by AB Biotek at 1 site in South Sudan.
Trial summary
In this study, we aim at assessing the benefits of dietary supplementation with ABB i5 and ABB C24, a combination of the the prebiotic ABB i5 and the postbiotic ABB C22, on the gut microbiota of people with constipation and on their gastrointestinal well-being. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Constipation
- What is being tested?
- ABB i5 and ABB C24
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteSouth Sudan
- Study dates
- 25 Apr 2023to 4 Apr 2024
- Phase
- Early Phase 1
- 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
- Subjects who require hospitalization
- Constipation defined as the Rome IV criteria for constipation
- 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 last palliative care en stage of "end of life" or "terminal"
- Amytriptilin (anti-depressive) and masalazine (anti-inflammatory) treatment
- Laxatives
- Antibiotic treatment in the previous 2 weeks
- Patients with IBS or any other gastrointestinal conditions that maybe the cause of the constipation
Trial locations and contacts
1 site in 1 country.
South Sudan1 site
Isabel Roig
Barcelona, Barcelona, 08030
About this study
In this study, we aim at assessing the benefits of dietary supplementation with ABB i5 and ABB C24, a combination of the the prebiotic ABB i5 and the postbiotic ABB C22, on the gut microbiota of people with constipation and on their gastrointestinal well-being.
- Conditions
- Constipation
- Being tested
- ABB i5, ABB C24
- Keywords
- constipation, prebiotic, postbiotic, gastrointestinal, dietary supplement
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABB i5Dietary supplement
Prebiotic ABB i5 (NextDext®, 5g)
ABB C24Dietary supplement
ABB C24: Prebiotic ABB i5 (NextDext®, 5g) + yeast postbiotic ABB C22 (200 mg) in sachets containing 5,2 g
| Study group | Role | What they receive |
|---|---|---|
| ABB i5 | Experimental | Prebiotic ABB i5 (NextDext®, 5g) Receives: Dietary Supplement: ABB i5 |
| ABB C24 | Experimental | ABB C24: Prebiotic ABB i5 (NextDext®, 5g) + yeast postbiotic ABB C22 (200 mg) in sachets containing 5,2 g Receives: Dietary Supplement: ABB C24 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbiota composition
Changes in microbiota composition through Shanon diversity test and statistical analyses (Continuous variables will be described as mean and standard deviation (SD) or as median and interquartile range; and categorical variables such as absolute frequencies and percentages).
Measured: from baseline to day 14 of supplementation
Secondary outcomes (3)
Transit time
transit time measured as methane on breathe testing
Measured: from baseline to day 14 of supplementation
Tolerance and gastro-intestinal comfort
Tolerance and gastro-intestinal comfort (validated questionnaires) life questionnaire: the Digestion-associated Quality of Life Questionnaire (DQLQ)
Measured: from baseline to day 14 of supplementation
Brain Derived Neurotrophic Factor (BDNF)
levels of Brain Derived Neurotrophic Factor (BDNF) (pg/mL)
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.
- First posted17 Dec 2024
- Study start25 Apr 2023
- Primary completion4 Apr 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 ConstipationStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- AB Biotek
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Grupo Colisée
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06738433
- Sponsor's protocol ID
- ABB i5/ABB C24
- Acronym
- ABB i5/ABB C24
- Status last verified
- Dec 2024
- First submitted
- 13 Dec 2024
- Last updated
- 17 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Statistical results on microbiological data.
Publications
Culqui Levano DR, Rodriguez Sanz P, Palacios Sanchez R, Saldana Miranda MY, Santa Cruz Lopez CY, Mateus Rodriguez JA. Impact of prebiotics and postbiotics in the management of constipation: Analysis of their differentiated modulation of intestinal microbiota. Clin Nutr ESPEN. 2025 Oct;69:625-633. doi: 10.1016/j.clnesp.2025.08.003. Epub 2025 Aug 6.
PubMed 40780410
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Tolerability of ABB I5 Prebiotic and ABB C22 Postbiotics for the Management of Constipation and Gastrointestinal Well-being: a Pilot Trial
- ClinicalTrials.gov ID
- NCT06738433
- Acronym / sponsor ID
- ABB i5/ABB C24 / ABB i5/ABB C24
- Conditions
- Constipation
- Keywords
- constipation, prebiotic, postbiotic, gastrointestinal, dietary supplement
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- AB BiotekIndustry (pharma, biotech, devices)
- Collaborators
- Grupo Colisée
- Study start
- 25 Apr 2023 (actual)
- Primary completion
- 4 Apr 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.
In this study, we aim at assessing the benefits of dietary supplementation with ABB i5 and ABB C24, a combination of the the prebiotic ABB i5 and the postbiotic ABB C22, on the gut microbiota of people with constipation and on their gastrointestinal well-being.
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 |
|---|---|---|
| ABB i5 | Experimental | Dietary Supplement: ABB i5Prebiotic ABB i5 (NextDext®, 5g) |
| ABB C24 | Experimental | Dietary Supplement: ABB C24ABB C24: Prebiotic ABB i5 (NextDext®, 5g) + yeast postbiotic ABB C22 (200 mg) in sachets containing 5,2 g |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects who require hospitalization
- Constipation defined as the Rome IV criteria for constipation
- Patients with the ability to take the study product orally
Key exclusion criteria (7 listed)
- 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 last palliative care en stage of "end of life" or "terminal"
- Amytriptilin (anti-depressive) and masalazine (anti-inflammatory) treatment
- Laxatives
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 i5Prebiotic ABB i5 (NextDext®, 5g) | Dietary supplement | ABB i5 |
| ABB C24ABB C24: Prebiotic ABB i5 (NextDext®, 5g) + yeast postbiotic ABB C22 (200 mg) in sachets containing 5,2 g | Dietary supplement | ABB C24 |
Primary outcome
Microbiota composition
Time frame: from baseline to day 14 of supplementation
Changes in microbiota composition through Shanon diversity test and statistical analyses (Continuous variables will be described as mean and standard deviation (SD) or as median and interquartile range; and categorical variables such as absolute frequencies and percentages).
3 secondary outcomes
Transit time
Time frame: from baseline to day 14 of supplementation
Tolerance and gastro-intestinal comfort
Time frame: from baseline to day 14 of supplementation
Brain Derived Neurotrophic Factor (BDNF)
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 17 Dec 2024.
- Derived from this study: PubMed 40780410Culqui Levano DR, Rodriguez Sanz P, Palacios Sanchez R, Saldana Miranda MY, Santa Cruz Lopez CY, Mateus Rodriguez JA. Impact of prebiotics and postbiotics in the management of constipation: Analysis of their differentiated modulation of intestinal microbiota. Clin Nutr ESPEN. 2025 Oct;69:625-633. doi: 10.1016/j.clnesp.2025.08.003. Epub 2025 Aug 6.
- Individual participant dataSharing planned: Yes. Statistical results on microbiological data.
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Outcome Research in Bowel Irrigation Techniques for the Treatment of Chronic Constipation and/or Faecal Incontinence
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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.
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?
A Early Phase 1 study testing ABB i5 and ABB C24 in people with Constipation, run by AB Biotek at 1 site in South Sudan.
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 3 inclusion and 7 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 17 Dec 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 South Sudan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Microbiota composition (time frame: from baseline to day 14 of supplementation). 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 NCT06738433, 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 17 Dec 2024.