NCT06005506

Brief Summary

The objective of the study will be to understand whether a supplementation of the diet with an active symbiotic, i.e. characterized by a mix of probiotics and a specially selected fiber with prebiotic activity combined with a vegetable extract with beneficial activities on carbohydrate and lipid metabolism, can reduce the relative inflammatory potential and improve absorption, intestinal motility and bowel habit of patients with various pathological conditions, such as ALS, ADHD and bronchial asthma.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2021

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 10, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 22, 2023

Completed
Last Updated

August 22, 2023

Status Verified

August 1, 2023

Enrollment Period

1.1 years

First QC Date

July 10, 2023

Last Update Submit

August 21, 2023

Conditions

AdhdALSBronchial Asthma

Outcome Measures

Primary Outcomes (2)

  • Change in levels of Short Chain Fatty Acids (SCFA)

    Evaluation of pre-post treatment variation of the level of specific SCFAs (acetic acid, propionic acid, butyric acid and valeric acid) both within the group of the treated and between the group of treated patients and the placebo group.

    Before and After 3 months of intervention

  • Change in levels of branched chain fatty acids (isobutyrate and isovalerate)

    Evaluation of the pre-post nutritional variation of the level of branched chain fatty acids (isobutyrate and isovalerate) between the group of treated patients and the placebo group

    Before and After 3 months of intervention

Secondary Outcomes (9)

  • Conners' Parent Rating Scale-Revised - scale H (ADHD Index)

    Before and After 3 months of intervention

  • Conners' Parent Rating Scale-Revised - Scale K (total CGI)

    Before and After 3 months of intervention

  • Conners' Parent Rating Scale-Revised - Scale B (attention problem)

    Before and After 3 months of intervention

  • Conners' Parent Rating Scale-Revised - Scale C ( hyperactivity)

    Before and After 3 months of intervention

  • Amyotrophic Lateral Sclerosis Functional Rating Scale - revised (ALSFRS-r)

    Before and After 3 months of intervention

  • +4 more secondary outcomes

Study Arms (2)

Probiotic + fiber

ACTIVE COMPARATOR

These subjects will be given a passive symbiotic preparation again consisting of two sticks of 1500mg each to be taken once a day: * Purple Sachet - Prebiotic - Composed of 500mg acacia fiber (Fibregum®) with high prebiotic activity and 500mg mai starch. Excipients and flavorings. * White Sachet - Probiotic - 30 Billion bacterial strains Lactobacillus plantarum LP (PBS067- EU Collection DSM 24937), Lactobacillus acidophilus L.

Dietary Supplement: Dietary fiberDietary Supplement: Probiotic

Probiotic + Prebiotic

EXPERIMENTAL

These subjects will be given an active symbiotic preparation consisting of two differently colored sticks of 1500mg each to be taken once a day: * Purple Sachet - Active Prebiotic - 500 mg of Fibregum®, a slow-fermenting prebiotic fiber and 500 mg of standardized extract of pigmented Zea Mays L fruit, rich in anthocyanins and polyphenols. Excipients and flavorings. * White Sachet - Probiotic - 30 Billion Bacterial Strains Lactobacillus plantarum LP (PBS067- EU Collection DSM 24937), Lactobacillus acidophilus LA (PBS066 - EU Collection DSM 24936) and Bifidobacterium animalis subsp. lactis BL (BL050 - Eu Collection DSM 25566).

Dietary Supplement: Prebiotic fiberDietary Supplement: Probiotic

Interventions

Prebiotic fiberDIETARY_SUPPLEMENT

Moradyn active prebiotic fiber product

Probiotic + Prebiotic
Dietary fiberDIETARY_SUPPLEMENT

Fibregum non-active fiber product

Probiotic + fiber
ProbioticDIETARY_SUPPLEMENT

Defense Plus probiotic complex

Probiotic + PrebioticProbiotic + fiber

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Age at enrollment ≥18 years;
  • ALS diagnosis defined or probable according to El Escorial criteria (Brooks et al., 2000);
  • Respiratory function with FVC% \>50%.

You may not qualify if:

  • Subjects unable to give informed consent to the study;
  • presence of psychiatric disease or severe cognitive impairment;
  • presence of tracheotomy; presence of severe pre-existing gastrointestinal disease (e.g., ulcerative rectocolitis; Crohn's disease).
  • Population 2: ADHD
  • children between 6 and 16 years old
  • children with ADHD, diagnosed with DSM-5 criteria and in accordance with the protocol shared by the Regional ADHD Reference Centers Lombardy.
  • presence of intellectual disability (QIT\<70),
  • presence of neurological diseases, epilepsy
  • presence of genetic syndromes
  • treatment with drug therapies.
  • Population 3: Bronchial Ashtma
  • adults above 18 years of age
  • diagnosed with Bronchial Ashtma following ERS-ETS criteria
  • life expectancy less than 18 months
  • active respiratory infections
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Scientific Institute IRCCS Eugenio Medea

Bosisio Parini, LC, 23842, Italy

Location

Alessia Fumagalli

Casatenovo, LC, 23880, Italy

Location

IBBA-CNR

Milan, 20133, Italy

Location

Centro Clinico NEMO - Fondazione Serena Onlus, Milano

Milan, 20162, Italy

Location

Related Publications (1)

  • Trezzi S, Scaccabarozzi G, Nossa R, Piazza C, Bianchi AR, Rosi E, Tizzoni F, Mauri M, Camillo L, Baragetti A, Molteni M, Campanella V, Mauro L, Cremonesi P, Severgnini M, Monroy MM, Castiglioni B, Sparvoli F, Pisano S, Pozzi M, Crippa A, Nobile M. Behavioural, cognitive, and neurophysiological effects of a synbiotic supplementation enriched with pigmented corn extract or cornstarch in drug-naive children with attention-deficit hyperactivity disorder: A randomised, double-blind, comparison-controlled clinical trial. Clin Nutr ESPEN. 2025 Feb;65:408-417. doi: 10.1016/j.clnesp.2024.12.016. Epub 2024 Dec 20.

    PMID: 39710171DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with HyperactivityAsthma

Interventions

Dietary FiberProbiotics

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental DisordersBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Dietary CarbohydratesCarbohydratesFoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesDietary Supplements

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2023

First Posted

August 22, 2023

Study Start

October 1, 2021

Primary Completion

October 31, 2022

Study Completion

March 31, 2023

Last Updated

August 22, 2023

Record last verified: 2023-08

Locations

IT(4)