Dietary Supplement (Beta-Glucans) in Allergic Patients Undergoing Subcutaneous Immunotherapy.

NCT06448585 | Completed Phase 4

• 1 other identifier: 90//2024
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The present study will attempt to determine if the dietary supplement, based on a synergistic combination of β-glucans and Saccharomyces cerevisiae yeast enriched with Zinc and Selenium, can improve the immune response in allergic patients diagnosed with rhinitis or rhinoconjunctivitis, with or without controlled asthma, who are undergoing subcutaneous polymerized 100 immunotherapy with a rapid initiation protocol. It will also attempt to determine if the dietary supplement in combination with DAO enzyme could improve the immunological response to immunotherapy.

Conditions

Rhinitis; Allergic Rhinoconjunctivitis; Rhinoconjunctivitis; Controlled Asthma; Uncontrolled Asthma

Keywords

Rhinitis; Allergic rhinoconjunctivitis; Controlled asthma; Subcutaneous polymerized 100 cluster immunotherapy; Beta-glucans and yeast Saccharomyces cerevisiae; Subcutaneous immunotherapy; Multicenter study; Prospective study; Controlled group; Longitudinal study; Randomized study

Outcome Measures

Primary Outcomes (1)

• Effectiveness of the dietary supplement

  To evaluate the effectiveness of the dietary supplement on the immune response in allergic patients by determining the levels of immunoglobulins and IgE subclasses (Total IgE, specific IgE, and IgG4) in serum.

  (T0) before the study. (T1) at 30 days. (T2) at 60 days. (T3) and sample collection at 90 days. (T4) and sample collection at 180 days.

Secondary Outcomes (5)

• Monitoring of health status (quality of life) in the different phases of the study using the SF-36 Quality of Life Questionnaire.

  (T0) before the study. (T1) at 30 days. (T2) at 60 days. (T3) and sample collection at 90 days. (T4) and sample collection at 180 days.

• Safety (assessment in the different study periods following intake of the dietary supplement)

  (T0) before the study. (T1) at 30 days. (T2) at 60 days. (T3) and sample collection at 90 days. (T4) and sample collection at 180 days.

• TSQM Spanish version questionnaire

  (T0) before the study. (T1) at 30 days. (T2) at 60 days. (T3) and sample collection at 90 days. (T4) and sample collection at 180 days.

• • Monitoring treatment compliance/adherence.

  (T0) before the study. (T1) at 30 days. (T2) at 60 days. (T3) and sample collection at 90 days. (T4) and sample collection at 180 days.

• SF-36 Quality of Life Questionnaire

  (T0) before the study. (T1) at 30 days. (T2) at 60 days. (T3) and sample collection at 90 days. (T4) and sample collection at 180 days.

Study Arms (4)

Placebo Stage 1 (first 90 days)

PLACEBO COMPARATOR

Control group (n= 30): Stage 1: Under treatment with subcutaneous immunotherapy (ITE) but not receiving any dietary supplement, serving as a comparison for the variables collected in the study, for 90 days.

Drug: Specific immunotherapy (SIT) treatment

Dietary supplement Stage 1 (first 90 days)

EXPERIMENTAL

Experimental group (n= 30): Stage 1: Participants receive the dietary supplement (1 sachet/day; contains 3 grams), in addition to the ITE treatment, for 90 days.

Drug: Specific immunotherapy (SIT) treatment; Dietary Supplement: Dietary Supplement: ABB C1

Placebo Stage 2 (last 90 days)

PLACEBO COMPARATOR

Stage 2: In addition to the ITE treatment, they receive the dietary supplement (1 sachet/day; contains 3 grams), but they do not receive the pork extract with diamine oxidase enzyme and serve as a comparison for the variables collected in the study, for 90 days.

Drug: Specific immunotherapy (SIT) treatment; Dietary Supplement: Dietary Supplement: ABB C1

Dietary supplement Stage 2 (last 90 days)

EXPERIMENTAL

Stage 2: In addition to the ITE treatment, they receive the dietary supplement (1 sachet/day; contains 3 grams) and mini-tablets with pork extract containing diamine oxidase enzyme (3 mini-tablets/day), for 90 days.

Drug: Specific immunotherapy (SIT) treatment; Dietary Supplement: Dietary Supplement: ABB C1; Dietary Supplement: Mini-tablets with pork extract

Interventions

Specific immunotherapy (SIT) treatment DRUG

Treatment with subcutaneous polymerized 100 specific immunotherapy (SIT) in its initiation phase with rapid (clustered) dosing, where the highest allergen concentration (0.2 + 0.3 mL) is administered directly, with an interval of 30 to 45 minutes between injections, in allergology consultations of the SES.

Also known as: Treatment with subcutaneous polymerized specific immunotherapy (ITE), allergen-specific immunotherapy (AIT)

Dietary supplement Stage 1 (first 90 days); Dietary supplement Stage 2 (last 90 days); Placebo Stage 1 (first 90 days); Placebo Stage 2 (last 90 days)

Dietary Supplement: ABB C1 DIETARY_SUPPLEMENT

Ingredients: betaglucanos, levadura Saccharomyces cerevisiae, selenio y zinc. 1 sachet/day; contains 3 grams

Dietary supplement Stage 1 (first 90 days); Dietary supplement Stage 2 (last 90 days); Placebo Stage 2 (last 90 days)

Mini-tablets with pork extract DIETARY_SUPPLEMENT

Mini-tablets with pork extract containing the diamine oxidase enzyme (3 mini-tablets/day)

Dietary supplement Stage 2 (last 90 days)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 65 years.
• Both sexes.
• Patients diagnosed with allergic rhinitis or allergic rhinoconjunctivitis, with or without allergic asthma due to sensitization to aeroallergens, undergoing treatment with subcutaneous polymerized 100 immunotherapy, initiating treatment with rapid dosing.
• Normoglycemia (fasting glucose ≤ 100 mg/dL).
• BMI between 18.5-29.9 kg/m².

You may not qualify if:

• Refusal to sign the informed consent.
• Outside the age range specified for the study.
• Presence of intolerance or hypersensitivity to selenium or zinc, or to any of the components of the dietary supplement individually.
• Participation in a clinical trial within the past two months, or currently participating in another study.
• Personal history of liver or kidney disease.
• Excessive alcohol consumption (\> 20 grams/day) or use of substance abuse.
• Any condition that, in the opinion of the investigators, renders the subject unable to participate in the study.

Sponsors & Collaborators

• Gala Servicios Clinicos S.L.: lead

Study Sites (1)

GALA Laboratories

Don Benito, Badajoz, 06400, Spain

Location

Related Publications (3)

• Garcia-Martin E, Garcia-Menaya J, Sanchez B, Martinez C, Rosendo R, Agundez JA. Polymorphisms of histamine-metabolizing enzymes and clinical manifestations of asthma and allergic rhinitis. Clin Exp Allergy. 2007 Aug;37(8):1175-82. doi: 10.1111/j.1365-2222.2007.02769.x.

  PMID: 17651147 BACKGROUND

• Rodriguez JAM, Bifano M, Roca Goma E, Plasencia CM, Torralba AO, Font MS, Millan PR. Effect and Tolerability of a Nutritional Supplement Based on a Synergistic Combination of beta-Glucans and Selenium- and Zinc-Enriched Saccharomyces cerevisiae (ABB C1(R)) in Volunteers Receiving the Influenza or the COVID-19 Vaccine: A Randomized, Double-Blind, Placebo-Controlled Study. Nutrients. 2021 Dec 2;13(12):4347. doi: 10.3390/nu13124347.

  PMID: 34959898 BACKGROUND

• Calderon MA, Cox L, Casale TB, Moingeon P, Demoly P. Multiple-allergen and single-allergen immunotherapy strategies in polysensitized patients: looking at the published evidence. J Allergy Clin Immunol. 2012 Apr;129(4):929-34. doi: 10.1016/j.jaci.2011.11.019. Epub 2012 Jan 11.

  PMID: 22244595 BACKGROUND

MeSH Terms

Conditions

Rhinitis

Interventions

Therapeutics; Pork Meat

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Red Meat; Meat; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Juan Antonio Carrillo, Medicine

  Universidad de Extremadura

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Multicenter, prospective, controlled group, longitudinal, and randomized study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multicenter, prospective, controlled group, longitudinal, and randomized study

Study Record Dates

• First Submitted: June 4, 2024
• First Posted: June 7, 2024
• Study Start: May 29, 2024
• Primary Completion: May 29, 2024
• Study Completion: December 10, 2024
• Last Updated: August 29, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)