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| Name | Class |
|---|---|
| Alyatec | INDUSTRY |
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The goal of this clinical trial is to learn if a probiotic formulation consisting of multiple bacterial strains has a positive effect on the quality of life of participants with chronic perennial allergic rhinitis symptoms. The researchers will also study whether the probiotic formulation influences the symptoms of allergic rhinitis. Participants with allergies to house dust mite, cats and/or dogs will be included in the study.
The main questions it aims to answer are:
Does the probiotic formulation have an impact of the quality of life of the participants? Does the probiotic formaluation have an effect on the severity of the symptoms of allergic rhinitis? Are there differences in the effects depending on the allergies the participants have?
Researchers will compare the probiotic formulation to a placebo (a substance that contains no probiotic bacteria but looks, smells, and tastes the same) to see if the probiotic formulation improves the quality of life of participants with chronic allergic rhinitis. In addition, also a GI symptom questionnaire will be filled in by the participants weekly
Participants will visit the clinic for the screening, and at the start, and at the end of the intervention for checkups and sampling. During the intervention they will take the probiotic formulation or a placebo twice every day for 12 weeks. They will keep a diary of their symptoms and note whenever they use anti-histamines and every two weeks they will fill in a questionnaire about their quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic | Active Comparator | Participants receive a multispecies probiotic formulation for oral use |
|
| Placebo | Placebo Comparator | The participants receive a placebo for oral use, comparable in appearance and smell as the probiotic formulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multi-species probiotic powder for oral solution. Dietary supplement containing six bacterial strains (Lactobacillus and Bifidobacterium species) | Dietary Supplement | The probiotic powder is provided in sachets. The Participants dissolve the powder in water and ingest twice daily for 12 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| The primary efficacy endpoint is the change in the global score of the mini-Rhinoconjunctivitis Quality of Life Questionnaire (mini-RQLQ) from baseline to week 12 of intervention | An improvement on quality of life is considered clinically meaningful when improved with ≥0.7 points in global and domain-specific mini-RQLQ scores between intervention and placebo | From baseline to 12 weeks of intervention |
| Measure | Description | Time Frame |
|---|---|---|
| The impact of intervention in rhino conjunctivitis quality of life will be assessed by the changes in global and domain-specific mini-RQLQ scores from baseline to week 12 of intervention every two weeks. | Every two weeks from baseline to end of treatment at 12 weeks | |
| The proportion of participants reporting a clinical relevant improvement on quality of life in global and domain-specific mini-RQLQ scores between intervention and placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between change from baseline in GSRS total score and changes in gut microbiome composition and fecal metabolite concentrations at Week 12 | Associations between gastrointestinal symptom changes, as measured by the Gastrointestinal Symptom Rating Scale (GSRS; 15 items, 7-point Likert scale), and changes in gut microbiome composition and fecal metabolite concentrations will be explored. Microbiome profiling will be performed using 16S rRNA sequencing of stool samples, and metabolite analysis will include short-chain fatty acids (SCFAs), bile acids, and other metabolites identified through untargeted metabolomics. Correlation analyses (e.g., Spearman's rank correlation) and/or linear regression models will be applied. Additional multivariate or network analyses may be used to explore complex interaction patterns. These analyses are exploratory and hypothesis-generating; no formal adjustment for multiple testing will be applied. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kitty Maassen, PhD | Contact | +31647210612 | k.maassen@winclove.nl | |
| Maria Stolaki, MSc | Contact | m.stolaki@winclove.nl |
| Name | Affiliation | Role |
|---|---|---|
| Alina GHERASIM, MD | ALYATEC clinical center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ALYATEC clinical center | Recruiting | Strasbourg | Alyatec | 67000 | France |
Individual participant data (IPD) will not be shared. Only aggregated and anonymized data will be analyzed and reported. The individual participant data are collected and managed by the contract research organization (CRO) and remain confidential. Data will be presented in summary form in scientific publications and regulatory submissions only.
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|
| Placebo Powder for Oral Solution | Dietary Supplement | The placebo powder is provided in sachets. The Participants dissolve the powder in water and ingest twice daily for 12 weeks. |
|
The proportion of participants reporting a clinical relevant improvement on quality of life will be assessed by the difference in proportion of participants achieving a clinically meaningful improvement (≥0.7 points) in global and domain-specific mini-RQLQ scores between intervention and placebo |
| From baseline to end of treatment at 12 weeks |
| The proportion of participants reporting a clinical relevant improvement on allergic rhinoconjuctivitis symptoms in global and domain-specific TSS scores between intervention and placebo | The proportion of participants reporting a clinical relevant improvement on allergic rhinoconjuctivitis symptoms will be assessed by the difference in proportion of participants achieving a clinically meaningful improvement (≥20%) in global and domain-specific TSS scores between intervention and placebo | From baseline to end of treatment at 12 weeks |
| The impact of a multispecies probiotic formulation on allergic rhinoconjunctivitis severity will be assessed by the difference in TSS mean (global and per item) between intervention and placebo over 12 weeks. | From baseline to end of treatment at 12 weeks, daily |
| The impact of a multispecies probiotic formulation on allergic rhinoconjunctivitis severity with established perennial allergies will be assessed as the change in the global score of the TSS from baseline to week 12 of intervention. | From baseline to end of treatment at 12 weeks |
| Differences in TSS will be analysed in subgroups of participants based on type of allergy | Differences in TSS will be analysed in subgroups of participants based on type of allergy (HDM, HDM+Cat, HDM+Cat+Dog, Cat, Cat+Dog and Dog) | From baseline to end of treatment at 12 weeks, daily |
| Differences in TSS will be analysed in subgroups of participants based on allergy pattern | Differences in TSS will be analysed in subgroups of participants based on different allergy pattern (perennial vs perennial with seasonal allergies) | From baseline to end of treatment at 12 weeks, daily |
| Differences in TSS will be analysed in subgroups of participants based on baseline severity of TSS score | Differences in TSS will be analysed in subgroups of participants based on baseline severity as stratified by TSS scores as follows: 0-6 = mild, 7-12=moderate, 13-18 =moderate/severe, and 19-24= severe | From baseline to end of treatment at 12 weeks, daily |
| Differences in mini-RQLQ will be analysed in subgroups of participants based on type of allergy | Differences in mini-RQLQ will be analysed in subgroups of participants based on type of allergy (HDM, HDM+Cat, HDM+Cat+Dog, Cat, Cat+Dog and Dog) | From baseline to end of treatment at 12 weeks, two weekly |
| Differences in mini-RQLQ will be analysed in subgroups of participants based on allergy pattern | Differences in mini-RQLQ will be analysed in subgroups of participants based on on different allergy pattern (perennial vs perennial with seasonal allergies) | From baseline to end of treatment at 12 weeks, two weekly |
| Differences in mini-RQLQ will be analysed in subgroups of participants based on baseline severity of mini-RQLQ | Differences in mini-RQLQ will be analysed in subgroups of participants based on baseline severity as stratified by mini-RQLQ as follows: 0-1.5, 1.5-2.5, 2.5-3.5, 3.5-4.5, >4.5 | From baseline to end of treatment at 12 weeks, two weekly |
| Change in immune modulatory biomarkers (cytokines and IgE) at baseline compared to 12 weeks of intervention versus placebo | From baseline to end of treatment at 12 weeks |
| Change in amount of blood cells at baseline compared to 12 weeks of intervention versus placebo | From baseline to end of treatment at 12 weeks |
| Change in ratio of blood cell at baseline compared to 12 weeks of intervention versus placebo | From baseline to end of treatment at 12 weeks |
| Change in rescue medication use (antihistamines) will be expressed as a percentage of the completed daily diary entries over the 12 weeks intervention period | From baseline to end of treatment |
| Reduction in gastro-intestinal complaints will be assessed using the GSRS questionnaire after 12 weeks intervention versus placebo and across weekly time points | From baseline to end of treatment at 12 weeks and weekly between those timepoints |
| Reduction in allergic symptoms other than rhinitis (eczema, food allergy and intolerance) using Non-rhinoconjunctivitis allergy Questionnaire over the 12 weeks intervention versus placebo | From baseline to end of treatment at 12 weeks |
| Change in fecal microbiome profile or metabolites production (e.a SCFA and bile acids) will be analyzed after 12 weeks intervention versus placebo | From baseline to end of treatment at 12 weeks |
| From baseline to end of treatment at 12 weeks |
| ID | Term |
|---|---|
| D012221 | Rhinitis, Allergic, Perennial |
| D000092542 | Dust Mite Allergy |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C100843 | Lacteol |
| D012996 | Solutions |
| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
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