Symptoms and General Pathology

All Conditions

Skin and Connective Tissue Diseases

Necrosis

Psoriasis

Skin Diseases

Skin Diseases, Papulosquamous

Other Dietary Supplements

All Drugs and Chemicals

Acidophilus

In the treatment group, intervention was given in the form of standard therapy and probiotic Lactobacillus plantarum IS 10605 in the amount of 2x1010 CFU for 12 weeks.

In the placebo group, intervention was given in the form of standard therapy and placebo 2x1 sachets for 12 weeks.

Healthy control group was not given any treatment. Stool samples were taken to examine the gut microbiota profile.

Indonesian original probiotic, given in capsule form with a dose of 2 x 1010 CFU

Lactobacillus Plantarum IS-10506

Placebo is an empty drug, given in capsule form with a dose of 2x1 sachets

Placebo

Menul Ayu Umborowati, Specialist

Menul Ayu Umborowati

Psoriasis is a chronic inflammatory skin disease (chronic and recurrent) which is influenced by various factors, namely genetics, immunological processes, and environmental triggers such as infection, obesity, smoking, and drugs.

The provision of probiotic Lactobacillus plantarum IS-10506, an Indonesian original probiotic strain, is expected to be an effective, safe, and affordable alternative for psoriasis treatment for psoriasis patients in Indonesia.

This study aimed to evaluate changes in gut microbiota profile, cytokines IL-17, TNF-a, IL-10, Foxp3, and disease severity of psoriasis vulgaris patients after supplementation with Lactobacillus plantarum IS-10506. The results of this study are expected to be the basis for the use of Lactobacillus plantarum IS-10506 in the therapy of psoriasis vulgaris which is included in the Clinical Practice Guide in Indonesia, which will ultimately help improve the quality of life of psoriasis patients.

Psoriasis is a chronic inflammatory skin disease (chronic and recurrent) which is influenced by various factors, namely genetics, immunological processes, and environmental triggers such as infection, obesity, smoking, and drugs. Psoriasis can increase the incidence of other diseases such as joint disorders, cardiovascular disorders, and psychological. Symptoms of psoriasis on the skin are red, well-defined plaques covered with thick, white, layered scales. The incidence of psoriasis is quite large, known to affect 0.09 - 11.4% of the world's population with rates varying between regions. Data in Indonesia is estimated that there are 2-6 million psoriasis sufferers in 2010, with a prevalence range of 1-3% in several teaching hospitals. During the period from 2016 to 2018, psoriasis vulgaris patients in the outpatient unit of RSUD Dr. Soetomo Surabaya recorded as many as 208 or 0.46% of all skin patients.

One of the mechanisms of psoriasis is abnormalities in Treg cells (cells that play a role in expressing Foxp3), resulting in an imbalance in the immune system with the dominance of T helper 1 (Th1) and T helper 17 (Th17) cells. In addition, the composition of the gut microbiota (collection of bacteria) in psoriasis patients is different from that of healthy people. The composition of the gut microbiota can be influenced by race, geography, and eating habits. Until now there has been no report on the intestinal microbiota profile of psoriasis patients in Indonesia.

The provision of probiotic Lactobacillus plantarum IS-10506, is expected to be an effective, safe, and affordable alternative for psoriasis treatment for psoriasis patients in Indonesia. Lactobacillus plantarum IS-10506 is produced from Dadih, a traditional fermented milk from West Sumatra, Indonesia. This probiotic is expected to be most compatible with the composition of the gut microbiota of Indonesians because it comes from an environment with similar exposure to pathogenic bacteria.

This study aimed to evaluate changes in gut microbiota profile, cytokines IL-17, TNF-a, IL-10, Foxp3, and disease severity of psoriasis vulgaris patients after supplementation with Lactobacillus plantarum IS-10506. The results of this study are expected to be the basis for the use of Lactobacillus plantarum IS-10506 in the therapy of psoriasis vulgaris which is included in the Clinical Practice Guide in Indonesia, which will ultimately help improve the quality of life of psoriasis patients.

A double blinded randomized clinical trial using a prospective cohort method in psoriasis vulgaris patients with purposive sampling.

Probiotic and placebo packaging are made the same, and drug code is randomized by pharmacy

Clinical Trial of Probiotic Supplementation in Psoriasis Vulgaris

Analysis of Gut Microbiota, Psoriasis Area and Severity Index, Interleukin-17, Tumor Necrosis Factor -α, Interleukin-10, and Foxp3 in Psoriasis Vulgaris After Supplementation With Lactobacillus Plantarum IS-10506

Alpha and beta diversity in gut microbiota profiles

Changes in serum levels of TNF-α, IL-17, IL-10, and Foxp3 by ELISA method

Changes in PASI scores after the intervention

Changes in the score of impaired quality of life due to skin diseases experienced using the DLQI questionnaires

Universitas Airlangga

Dr. Soetomo General Hospital

doctor, dermatovenereologist

Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma, Squamous Cell

Breast Neoplasms

Triple Negative Breast Neoplasms

Uterine Cervical Neoplasms

Melanoma

Carcinoma, Renal Cell

Small Cell Lung Carcinoma

Head and Neck Neoplasms

Carcinoma

Neoplasms, Squamous Cell

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Neoplasms by Histologic Type

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Breast Diseases

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Kidney Neoplasms

Urologic Neoplasms

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Renal Cell Carcinoma

Small Cell Lung Cancer

Clear Cell Renal Cell Carcinoma

Antineoplastic Agents

Antibodies

Antibodies, Monoclonal

Durvalumab

Atezolizumab

Immunoglobulins

Antineoplastic Agents, Immunological

Participants will receive AZD8701 intravenously, on Day 1, 3, 5 and 8 and then weekly for a maximum of 2 years.

Participants will receive AZD8701 (intravenously, on Day 1, 3, 5 and 8 and then weekly) and durvalumab (MEDI4736) intravenously monthly for a maximum of 2 years.

AZD8701

The purpose of this study is to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Antitumor Activity of AZD8701 Alone and in Combination with Durvalumab (MEDI4736) in Adult Subjects with Select Advanced Solid Tumors

This is a Phase I, First in Human, multicentre, open-label, multiple arm study with dose escalations and expansions at selected doses. Dose-escalation will occur with AZD8701 in monotherapy (Part 1) and in combination with durvalumab (Part 3) in selected participants with HNSCC, TNBC, NSCLC, ccRCC, gastroesophageal cancer, melanoma, cervical cancer, small-cell lung cancer and/or participants with solid tumours who have demonstrated a response to prior PD-(L)1 treatment.

Disease specific expansions will occur with a selected dose of AZD8701 in participants with NSCLC (Part 2) and with a selected dose of AZD8701 and durvalumab in participants with TNBC and clear cell RCC (Part 4).

This is a Phase I, FIH, multicentre, open-label, multiple arm study. Dose-escalation will occur with AZD8701 in monotherapy and in combination with durvalumab in selected participants with HNSCC, TNBC, NSCLC, ccRCC, gastroesophgeal cancer, melanoma, cervical cancer, small-cell lung cancer and/or participants with solid tumours who have demonstrated a response to prior PD-(L)1 treatment.

Disease specific expansions will occur with a selected dose of AZD8701 in participants with NSCLC and with a selected dose of AZD8701 and durvalumab in participants with TNBC and clear cell RCC.

First Time in Human Study of AZD8701 With or Without Durvalumab in Participants With Advanced Solid Tumours

A Phase I First-in-Human Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of AZD8701 Administered Intravenously as Monotherapy and in Combination With Durvaluamb (MEDI4736) in Participants With Advanced Solid Tumours.

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.

All request will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Determined according to Incidence and treatment related AEs and SAEs

Determined according to Incidence of DLTs (during the first 28 day cycle)

Determined according to Incidence of abnormal vital signs and laboratory parameters

Safety and tolerability of the MTD/OBD/MFD assessed through incidence of AEs and SAEs

The proportion of subjects achieving a confirmed complete or partial response according to RECIST 1.1 by investigator assessment

Time from start of study treatment to the date of objective disease progression or death (by any cause in the absence of progression)

Time from first documented response (that is subsequently confirmed) to the date of objective disease progression or death (by any cause in the absence of progression)

The proportion of subjects with a best response of CR or PR in the first 16 weeks or SD for at least 16 weeks according to RECIST 1.1 by investigator assessment

Time from the start of study treatment until the date of first documented response (which is subsequently confirmed)

Best percentage change from baseline in sum of the diameters of target lesions

The survival rate of subjects at 18 months from start of treatment

Maximum concentration (Cmax) of AZD8701 in plasma

Time to maximum concentration (tmax) of AZD8701 in plasma

Exposure to AZD8701 through measurement of area under the curve (AUC) in plasma

Maximum concentration (Cmax) of AZD8701 in urine

Time to maximum concentration (tmax) of AZD8701 in urine

Exposure to AZD8701 through measurement of area under the curve (AUC) in urine

Urine samples will be collected to assess urine concentrations of AZD8701 at a series of timepoints to derive renal clearance

Maximum concentration (Cmax) of Durvalumab in serum

Minimum concentration (Cmin) of Durvalumab in serum

Percentage change in FOXP3 mRNA expression from pre-treatment (baseline) to post treatment

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Clinical Trial of Probiotic Supplementation in Psoriasis Vulgaris	NCT05254249	Psoriasis Vulga...	Lactobacillus P... Placebo	18 Years - 70 Years	Dr. Soetomo General Hospital
First Time in Human Study of AZD8701 With or Without Durvalumab in Participants With Advanced Solid Tumours	NCT04504669	Clear Cell Rena... Non-Small-Cell ... Triple Negative... Squamous Cell C... Small Cell Lung... Gastroesophagea... Melanoma Cervical Cancer Advanced Solid ...	AZD8701 Durvalumab	18 Years - 101 Years	AstraZeneca
Clinical Trial of Probiotic Supplementation in Psoriasis Vulgaris	NCT05254249	Psoriasis Vulga...	Lactobacillus P... Placebo	18 Years - 70 Years	Dr. Soetomo General Hospital

Spots Global Cancer Trial Database for foxp3

Every month we try and update this database with for foxp3 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for foxp3

Every month we try and update this database with for foxp3 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for foxp3 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.