NCT03598010 is a NA clinical trial of Actitan-F (7dd) in Diarrhea, sponsored by Aboca Spa Societa' Agricola.

Who is sponsoring NCT03598010?

NCT03598010 is sponsored by Aboca Spa Societa' Agricola.

What drugs are being tested in NCT03598010?

Interventions in NCT03598010: Actitan-F (7dd), Actitan-F (28dd).

What condition does NCT03598010 study?

NCT03598010 studies Diarrhea, Chronic Diarrhea, Acute Diarrhea, Diarrhea, Infantile.

Is NCT03598010 still recruiting?

NCT03598010 is currently status unknown. Last updated 31 May 2019.

Last reviewed 2019-05-31 · How we verify

NCT03598010

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Safety, Tolerability and Preliminary Efficacy of Oral Administration of Tannins and Flavonoids in the Management of Pediatric Diarrhea

Status unknown NA Last updated 31 May 2019

What this trial tests

NA trial testing Actitan-F (7dd) in Diarrhea in 240 participants. Status unknown.

Timeline

1 October 2019

Primary endpoint
1 December 2020

1 March 2021

Quick facts

Lead sponsor	Aboca Spa Societa' Agricola
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	240
Start date	1 October 2019
Primary completion	1 December 2020
Estimated completion	1 March 2021

Drugs / interventions tested

Actitan-F (7dd)
Actitan-F (28dd)

Conditions studied

Diarrhea — all drugs for Diarrhea →
Chronic Diarrhea — all drugs for Chronic Diarrhea →
Acute Diarrhea — all drugs for Acute Diarrhea →
Diarrhea, Infantile — all drugs for Diarrhea, Infantile →

Sponsor

Aboca Spa Societa' Agricola — full company profile →

Who can join

Adults 1 to 12, any sex, with Diarrhea or Chronic Diarrhea. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Acute (onset <7 days) or Prolonged Diarrhea (onset ≥7 and ≤14 days): Response Rate (RR) measured after 4 treatment days.
Time frame: Day0 to Day4
Acute (onset \<7 days) or Prolonged Diarrhea (onset ≥7 and \<14 days): Response Rate (RR) measured after 4 treatment days. Patients will be considered as responders if they have experienced the passage of 2 formed stools or no stool for at least 12 consecutive hours during the 4 days treatment.
Chronic Diarrhea (onset >14 days): Response Rate (RR) measured across the whole treatment period
Time frame: Day0 to Day28
Chronic Diarrhea (onset \>14 days): Response Rate (RR) measured across the whole treatment period (4 weeks). Patients will be considered as responders if they have experienced a 50% (or more) reduction in the number of days with at least 1 diarrheic stools (Bristol score 6 or 7) in the whole treatment period (4 weeks) compared to the 7 days prior the treatment (baseline).

Sponsor's own description

Evaluation of the efficacy of a treatment with Actitan-F, a natural molecular complex of tannins (from Agrimony and Tormentil) and flavonoids (Chamomile) in a pediatric population of children affected by acture/prolonged/chronic diarrhea

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other recruiting trials for Diarrhea

Currently open trials in the same condition.

NCT07285785 — Rifaximin 200 mg Plus Oral Rehydration vs Oral Rehydration Alone in Children With Acute Diarrhea · Phase 4 · recruiting
NCT07385196 — Defining Ileorectal Syndrome: a Prospective Observational Study · recruiting
NCT07205926 — First in Human Dose Escalation Study Evaluating the Safety and Immunogenicity of IVT's Shigella-04 Vaccine in Healthy Yo · Phase 1 · recruiting
NCT07484412 — Efficacy and Safety of Encapsulated Bifidobacterium Longum BBH016 in Subjects With Lower Gastrointestinal Symptoms · NA · active not recruiting
NCT06801067 — A Study of SER-155 to Treat Diarrhea in People on Immunotherapy · Phase 1 · recruiting

Other Aboca Spa Societa' Agricola trials

Trials by the same sponsor.

NCT05904938 — Oral Administration of Actitan-F in Paediatric Diarrhoea · NA · unknown
NCT05192317 — Administration of a Natural Molecular Complex in Functional Chronic Constipation · NA · unknown
NCT05016024 — Administration of a Molecular Complex of Resins, Polysaccharides and Polyphenols in Irritable Bowel Syndrome. · NA · completed
NCT03531372 — Mipolixin® Compared to Poliprotect® in Moderate Functional Dyspepsia and Heartburn. · NA · completed
NCT03545724 — Effectiveness & Safety of Neofitoroid® in Hemorrhoidal Disease · NA · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03598010 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Aboca Spa Societa' Agricola
Last refreshed: 31 May 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03598010.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing