SUSPENDED

A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Disease

Conditions

Gut MicrobiomeGastrointestinal MicrobiomeAutismAutism Spectrum DisorderAutism Spectrum Disorder High-FunctioningAlzheimer DiseaseAlzheimer Dementia (AD)Alzheimer DementiaAlzheimer Disease (AD)CrohnCrohn ColitisCrohn Disease (CD)Crohn Disease ColonMyalgic EncephalomyelitisME/CFSMyalgic Encephalomyelitis (ME)Myalgic Encephalomyelitis/Chronic Fatigue SyndromePsoriasisPsoriasis AnnularisPsoriasis ChronicChronic Urinary Tract InfectionUlcerative Colitis (Disorder)Ulcerative Colitis (UC)Ulcerative Colitis AcuteUlcerative Colitis ChronicMultiple SclerosisMultiple Sclerosis (MS) - Relapsing-remittingMultiple Sclerosis (MS) Primary ProgressiveConstipation Chronic IdiopathicConstipationCeliacCeliac DiseaseCeliac SprueLyme ArthritisLyme Borreliosis, Nervous SystemLyme Disease, ChronicCholesterolCholesterol Level, HighCancerColon CancerAmyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral SclerosisRheumatoid Arthritis (RA)Rheumatoid Arthritis - RheumatismChronic Fatigue Syndrome (CFS)PARKINSON DISEASE (Disorder)Parkinson DiseaseParkinson Disease (PD)DepressionMajor Depressive Disorder (MDD)Depression DisorderDepression in AdultsAnxietyAnxiety Disorder GeneralizedObsessive Compulsive Disorder (OCD)Obsessive Compulsive Disorder OCDObsessive - Compulsive DisorderBipolarBipolar 1 DisorderBipolar Disorder (BD)Bipolar Disorder I and IIBipolar and Related DisordersMigraineMigraine DisorderDiabetes (DM)DiabetesLupusLupus ErythematosusEpidermolysis Bullosa (EB)MesotheliomaMesothelioma MalignantIBS (Irritable Bowel Syndrome)Irritable BowelIBS - Irritable Bowel SyndromeIrritable Bowel Syndrome (IBS)EczemaEczema Atopic DermatitisAcneMyasthaenia GravisGoutMicrobiomeASDChronic UTIUlcerative ColitisUCMSChronic ConstipationCelic SprueLyme diseaseElevated CholesterolColorectal CancerALSRheumatoid ArthritisRAChronic FatigueChrohns colitisAlzheimerParkinsonmajor depressive disorderOCDObsessive-Compulsive disorderBiopolarBipolar disorderMigraine headacheDMDiabetes DMLupus eruthematosusEpidermolysis BullosaIBSIrritable Bowel SyndromeMyasthenia Gravis

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records.

Official Title

A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Disease

Quick Facts

Study Start:2019-07-11
Study Completion:2030-12-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:SUSPENDED

Study ID

NCT04031469

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 1. Signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study
  2. * 2. Male or female patients of any age (interest is given to children to compare with mothers).
  1. * 1. Refusal to sign informed consent form
  2. * 2. History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy.
  3. * 3. Postoperative stoma, ostomy, or ileoanal pouch
  4. * 4. Participation in any experimental drug protocol within the past 12 weeks
  5. * 5. Treatment with total parenteral nutrition
  6. * 6. Any clinically significant evidence of disease that could interfere with the subject's ability to enter the trial
  7. * 7. Inability to adequately communicate with the investigator or their respective designee and/or comply with the requirements of the entire study

Contacts and Locations

Principal Investigator

Sabine Hazan, MD
STUDY_DIRECTOR
ProgenaBiome

Study Locations (Sites)

Sabine Hazan
Ventura, California, 93003
United States

Collaborators and Investigators

Sponsor: ProgenaBiome

  • Sabine Hazan, MD, STUDY_DIRECTOR, ProgenaBiome

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-07-11
Study Completion Date2030-12-10

Study Record Updates

Study Start Date2019-07-11
Study Completion Date2030-12-10

Terms related to this study

Keywords Provided by Researchers

  • Microbiome
  • autism
  • ASD
  • Myalgic encephalomyelitis
  • ME/CFS
  • Psoriasis
  • Chronic UTI
  • Chronic Urinary Tract Infection
  • Ulcerative Colitis
  • UC
  • Multiple Sclerosis
  • MS
  • Chronic Constipation
  • Constipation
  • Celiac disease
  • Celic Sprue
  • Lyme disease
  • Elevated Cholesterol
  • Colorectal Cancer
  • Cancer
  • Amyotrophic Lateral Sclerosis
  • ALS
  • Rheumatoid Arthritis
  • RA
  • Chronic Fatigue
  • Alzheimer disease
  • Chrohns colitis
  • Crohn
  • Alzheimer
  • Parkinson
  • depression
  • major depressive disorder
  • OCD
  • Obsessive-Compulsive disorder
  • Biopolar
  • Bipolar disorder
  • Migraine
  • Migraine headache
  • Diabetes
  • DM
  • Diabetes DM
  • Lupus
  • Lupus eruthematosus
  • Epidermolysis Bullosa
  • Mesothelioma
  • IBS
  • Irritable Bowel Syndrome
  • Eczema
  • Acne
  • Myasthenia Gravis
  • Gout

Additional Relevant MeSH Terms

  • Gut Microbiome
  • Gastrointestinal Microbiome
  • Autism
  • Autism Spectrum Disorder
  • Autism Spectrum Disorder High-Functioning
  • Alzheimer Disease
  • Alzheimer Dementia (AD)
  • Alzheimer Dementia
  • Alzheimer Disease (AD)
  • Crohn
  • Crohn Colitis
  • Crohn Disease (CD)
  • Crohn Disease Colon
  • Myalgic Encephalomyelitis
  • ME/CFS
  • Myalgic Encephalomyelitis (ME)
  • Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
  • Psoriasis
  • Psoriasis Annularis
  • Psoriasis Chronic
  • Chronic Urinary Tract Infection
  • Ulcerative Colitis (Disorder)
  • Ulcerative Colitis (UC)
  • Ulcerative Colitis Acute
  • Ulcerative Colitis Chronic
  • Multiple Sclerosis
  • Multiple Sclerosis (MS) - Relapsing-remitting
  • Multiple Sclerosis (MS) Primary Progressive
  • Constipation Chronic Idiopathic
  • Constipation
  • Celiac
  • Celiac Disease
  • Celiac Sprue
  • Lyme Arthritis
  • Lyme Borreliosis, Nervous System
  • Lyme Disease, Chronic
  • Cholesterol
  • Cholesterol Level, High
  • Cancer
  • Colon Cancer
  • Amyotrophic Lateral Sclerosis (ALS)
  • Amyotrophic Lateral Sclerosis
  • Rheumatoid Arthritis (RA)
  • Rheumatoid Arthritis - Rheumatism
  • Chronic Fatigue Syndrome (CFS)
  • PARKINSON DISEASE (Disorder)
  • Parkinson Disease
  • Parkinson Disease (PD)
  • Depression
  • Major Depressive Disorder (MDD)
  • Depression Disorder
  • Depression in Adults
  • Anxiety
  • Anxiety Disorder Generalized
  • Obsessive Compulsive Disorder (OCD)
  • Obsessive Compulsive Disorder OCD
  • Obsessive - Compulsive Disorder
  • Bipolar
  • Bipolar 1 Disorder
  • Bipolar Disorder (BD)
  • Bipolar Disorder I and II
  • Bipolar and Related Disorders
  • Migraine
  • Migraine Disorder
  • Diabetes (DM)
  • Diabetes
  • Lupus
  • Lupus Erythematosus
  • Epidermolysis Bullosa (EB)
  • Mesothelioma
  • Mesothelioma Malignant
  • IBS (Irritable Bowel Syndrome)
  • Irritable Bowel
  • IBS - Irritable Bowel Syndrome
  • Irritable Bowel Syndrome (IBS)
  • Eczema
  • Eczema Atopic Dermatitis
  • Acne
  • Myasthaenia Gravis
  • Gout