Last updated: February 15, 2023
Sponsor: Aboca Spa Societa' Agricola
Overall Status: Completed
Phase
N/A
Condition
Colic
Lactose Intolerance
Gastrointestinal Diseases And Disorders
Treatment
N/AClinical Study ID
NCT05016024
ABO-COL-01/21
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Male or female patients aged 18 to 75 years (inclusive);
- Diagnosis of IBS according to ROME IV criteria (Appendix 3);
- Abdominal pain score ≥ 4 on a 11-point NRS, on at least 2 days of the 14 days priorto the baseline visit and on at least 2 days of the last 14 days of the washoutperiod, and pain score not > 8 in more than 7 days of each of the two above-mentionedperiods;
- Signed Informed Consent;
- Patients' ability to comply with the study procedures;
- Stable diet in the two months prior to the screening visit;
- *Negative colonoscopy, defined as the absence of clinically relevant changes or ofchanges nonetheless relevant in relation to study participation risk, performed duringthe run-in period, unless:
- a colonoscopy was performed within the previous 5 years and was negative asintended above, or, if more than one was performed within the previous 5 years,the last being negative as intended above;
- the symptoms, if any, for which the last colonoscopy was performed, have remainedunchanged;
- Postmenopausal female patients, i.e., females who have not had a menstrual periodfor at least 12 months or women who have undergone surgical sterilisation (tuballigation or ovary removal). If not, women of childbearing potential must followreliable contraceptive treatment.
- Inclusion criteria applicable only for patients > 50 years of age
Exclusion
Exclusion Criteria:
- Patients taking treatments that may significantly affect the efficacy outcomesmeasures, such as: probiotics and prebiotics (unless contained in milk-derived foodssuch as yogurt and cheese); drugs with adsorbent/sequestrant properties such asdiosmectite; 5-HT3 receptor antagonist drugs, e.g. ondasetron; drugs that modifygastro-intestinal motility, e.g. "final" anti-cholinergic agents such as loperamide,or cholinergic agents; laxatives and faecal softeners) unless they have been taken ata stable dose for at least four weeks prior to the screening visit.
- Patients taking tricyclic antidepressants within six months prior to the screeningvisit;
- Patients taking opioid-containing analgesics within one month prior to thescreening visit;
- Patients taking antibiotics within one month prior to the screening visit;
- Patients with relevant organic, systemic or metabolic disease, or laboratorychanges, that are deemed significant based on specific ranges of normality;
- Patients with organic bowel diseases;
- Patients with unstable psychiatric conditions;
- Patients who have undergone major abdominal surgery, except appendectomy;
- Known hypersensitivity to one or more of the components of the products.
- 10.Women with known or planned pregnancy or breastfeeding;
- 11.Patients with malignancies of any type, or with a history of prior malignancies,except for patients with a history of extra-intestinal malignancies that have beensurgically removed and have not relapsed within the five years prior to participation.
Study Design
Total Participants: 71
Study Start date:
August 05, 2021
Estimated Completion Date:
February 15, 2023
Study Description
Connect with a study center
Klinische Forschung Karlsruhe GmbH
Karlsruhe,
GermanySite Not Available
Istituto Clinico Humanitas
Rozzano, Milano 20089
ItalySite Not Available
Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari
Bari,
ItalySite Not Available
Azienda Ospedaliero Universitaria di Bologna
Bologna,
ItalySite Not Available
Ospedale SS. Annunziata
Chieti,
ItalySite Not Available
Azienda Ospedaliero Universitaria Pisana
Pisa, 56124
ItalySite Not Available
Policlinico Universitario A. Gemelli
Rome,
ItalySite Not Available

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