Probiotic Supplementation in Children Affected by Upper Respiratory Infections (PROBIOS2021)

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Active, not recruiting

Conditions: Upper Respiratory Tract Infection

Treatments: Dietary Supplement: Probiotic supplement; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06052540

726_2021bis

Details and patient eligibility

About

The goal of this randomized non-pharmacological Intervention study is to evaluate the effects of probiotic supplements (Bifidobacterium breve M-16V, Bifidobacterium lactis HN019, Lactobacillus rhamnosus HN001) on children affected by upper respiratory tract infections.

The main questions it aims to answer are:

• probiotic formulation can reduce intensity and duration of fever in children affected by upper respiratory tract infections
• probiotic formulation can influence the gut microbiota composition in children affected by upper respiratory tract infections

Participants will be asked to take probiotic supplements or placebo for 14 days and to collect three fecal samples: before probiotic supplementation (T0), 14 days after probiotic supplementation (T1), and 12 months after the enrollment (T2).

Enrollment: 128 patients

Sex: All

Ages: 29 days to 4 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Access to the Emergency room with fever and upper respiratory tract infection
• Age > 28 days and ≤ 4 years
• Signature of informed consent by parents or guardian

Exclusion criteria

• Presence of pathologies associated with immunosuppression or ongoing immunosuppressant treatments
• Hospitalisation/hospitalisation
• Diarrhea at enrollment
• No signed informed consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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128 participants in 2 patient groups, including a placebo group

Probiotics

Active Comparator group

Description:

Probiotic supplement: Mix of probiotic strails. Administration: 1 stick per day or 5 drops per day. Study duration for each patient: 14 days.

Treatment:

Dietary Supplement: Probiotic supplement

Placebo

Placebo Comparator group

Description:

Placebo: Medium Chain Triglycerides. Administration: 1 stick per day or 5 drops per day. Study duration for each patient: 14 days.

Treatment:

Dietary Supplement: Placebo