LenoDiar Pediatric acts thanks to Actitan-F, a plant-based molecular complex resulting from Aboca research which reduces attacks of diarrhoea and normalises the consistency of stools, helping to rapidly restore a balanced intestinal function.
Actitan-F counteracts the inflammation of the intestinal mucous membrane, always present in the case of diarrhoea, through two action mechanisms:
a protective action, achieved by forming a barrier-effect film to limit contact with microorganisms and irritants;
an antioxidant action on the free radicals which counteracts the irritation of the mucous membrane.

Diarrhea

Chronic Diarrhea

Acute Diarrhea

Diarrhea, Infantile

1 sack every 4 hours, maximum 4 sacks/day for 7 days.

Actitan-F (7dd)

1 sack every 4 hours, maximum 4 sacks/day for 28 days.

Actitan-F (28dd)

Safety, Tolerability and Preliminary Efficacy of Lenodiar Pediatric in Diarrhea

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

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 (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).

Number of episodes of daily watery evacuations evaluated by means of the electronic patient diaries;

Number of unformed stools passed per 24-h interval, after dosing evaluated by means of the electronic patient diaries

Number of treatment failures. A treatment failure is defined as clinical deterioration or worsening of symptoms or illness continuing after 120 h following the first dose evaluated by means of the electronic patient diaries

Difference in body weight between baseline and End of Treatment

Frequency and severity of diarrhea associated symptoms (nausea, vomiting, abdominal pain). Severity will be evaluated by means of a 0-4 Likert scale (0 = none; 1 = mild; 2 = moderate; 3 = severe; 4 = very severe);

Evaluation of the nr of sachets prescribed by the investigators and the % of compliance recorded

Proportion of patients requiring other treatments in addition to Lenodiar Pediatric or to other concomitant treatments prescribed at baseline visit for diarrhea symptoms relief (e.g. parenteral rehydration and/or other medications) evaluated by means of the electronic patient diaries

Change in results of the Pediatric Quality of Life Questionnaire (PedsQL) between baseline and End of Treatment visits

Change in results in parent assessment of children Quality of Life (100 mm VAS) between baseline and End of Treatment visits

Incidence of adverse events (AEs) and serious adverse events (SAEs), and rate of study discontinuations due to AEs/SAE;

Aboca Spa Societa' Agricola

These infants will receive aromatherapy, consisting of Lavender and Chamomile essential oils, in addition to standard care, which includes morphine replacement therapy, infant massage, PT, OT, and music therapy.

These infants receive standard care ONLY, which includes morphine replacement therapy, infant massage, PT, OT, and music therapy.

Standard Therapy ALONE

These infants will receive aromatherapy, consisting of Lavender and Chamomile essential oils, in addition to standard care, which includes morphine replacement therapy, infant massage, PT, OT, and music therapy.
lavender and chamomile essential oils: Our patches are obtained from BioEsse Technologies™. Each patch contains a 50:50 mixture of Lavender and Chamomile essential oils in a 55 microliter standard dose patch. The patches release the aromatherapy over a 2-8 hours period and the diffusion rate of each patch is identical. The back of the patch is layered with a hypoallergenic medical grade adhesive, similar to the material found on ECG leads.

Standard Therapy Plus Aromatherapy

Total

Sex: Female, Male

Race and Ethnicity Not Collected

Region of Enrollment

Birth Weight

Opioid Exposure Only

Multi-Drug Exposure

How long the infant remains hospitalized.

Length of Hospitalization

How long the infant requires medication to treat symptoms.

Length of Medication Therapy

Overall Study

John Bauer, MD

Neonatal Abstinence Syndrome

Aromatherapy

Our patches are obtained from BioEsse Technologies™. Each patch contains a 50:50 mixture of Lavender and Chamomile essential oils in a 55 microliter standard dose patch. The patches release the aromatherapy over a 2-8 hours period and the diffusion rate of each patch is identical. The back of the patch is layered with a hypoallergenic medical grade adhesive, similar to the material found on ECG leads.

lavender and chamomile essential oils

University of Kentucky

The Effect of Aromatherapy on Neonatal Abstinence Syndrome and Salivary Cortisol Levels

John M. Daniel

Fellow, Department of Pediatrics, Division of Neonatology

Colonic Diseases, Functional

CHT - herbal therapy

Hadassah Medical Organization

Combination Herbal Therapy (CHT) Versus Placebo in Patients With Irritable Bowel Syndrome (IBS)

A Phase I, Double-Blind, Placebo-Controlled, Randomized, Parallel-Group Study to Evaluate the Safety and Efficacy of a Combination Herbal Therapy (CHT), Versus Placebo in Improving the Overall Quality of Life and Symptoms in Patients With Irritable Bowel Syndrome (IBS)

matricaria perforata/caureja

Safety, Tolerability and Preliminary Efficacy of Lenodiar Pediatric in Diarrhea

The Effect of Aromatherapy on Neonatal Abstinence Syndrome and Salivary Cortisol Levels

Combination Herbal Therapy (CHT) Versus Placebo in Patients With Irritable Bowel Syndrome (IBS)

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