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NCT05573542Csak meghívásos

Early Signs of Parkinsons Disease in IBS

Early Signs of Parkinson's Disease Pathology in the Colon of Patients With Irritable Bowel Syndrome

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2024. ápr. 3. · Több mint 12 hónapja nem frissült - kérdezd meg a helyszínt, nyitott-e még

Következő lépések

Rövid összefoglaló (regiszter, angolul)

Bowel symptoms like constipation and abdominal pain are characteristic symptoms of irritable bowel syndrome (IBS). The pathogenesis and pathophysiology are not fully understood but subject to intense research, with emphasis on aberrations in the gut-brain axis, low-grade inflammation and gut barrier dysfunction that results in increased permeability and microbial translocation. Many patients with Parkinson's disease (PD) have reported bowel symptoms similar to that in IBS patients decades prior to the diagnosis of PD. Epidemiological studies show a significantly elevated risk of developing PD in IBS patients, though there is no knowledge on a pathogenic connection between these disorders. Recent studies show increased gut permeability and intestinal presence of pathological alpha-synuclein aggregates, the neuropathological hallmark in PD, indicating the involvement of the gut-brain axis. We aim to compare the presence of colonic alpha-synuclein between IBS, PD patients and healthy controls to relate these findings to intestinal permeability, ultrastructural mucosal changes, immune cell interactions, microbiota composition and brain function. This project could identify IBS groups at risk of developing PD and birth the development of early clinical diagnostic methods.

Állapot (regiszter)
Csak meghívásos
Vizsgálattípus
Megfigyeléses
Résztvevők száma
120 (tervezett)
Első benyújtás
2022. okt. 3.
Kezdés
2023. máj. 1.
Elsődleges befejezés
2027. okt.
Fő szponzor
Örebro University, Sweden
Betegségek
Parkinson-kór
NCT-szám
NCT05573542

Mit vállalsz

  • Vizsgálat típusa: Megfigyeléses
  • Tervezett résztvevők: 120
  • 2023. máj. 1. és az elsődleges befejezés (2027. okt.) között
  • 1 helyszín, 1 országban
  • Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket

A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.

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Korábbi kezelés

  • Concurrent or recent treatment with antibiotics (< 12 weeks)
  • Concurrent or recent (< 4 weeks) use of nutritional supplements or herb products affecting intestinal function or mood (e.g. aloe vera, St. John´s Wort and probiotics/prebiotics).
  • Comprehensive tooth-implants or prothesis.
  • Concurrent or recent treatment with antibiotics (< 12 weeks).
  • Concurrent or recent (< 4 weeks) use of nutritional supplements or herb products affecting intestinal function or mood (e.g. aloe vera, St. John´s Wort and probiotics/prebiotics).
  • Concurrent or recent treatment with drugs affecting intestinal microbiota, function or mood, e.g., antidepressants (< 12 weeks), antibiotics (< 12 weeks)
  • Concurrent or recent (< 4 weeks) use of nutritional supplements or herb products affecting intestinal function or mood (e.g. aloe vera, St. John´s Wort and probiotics/prebiotics).
  • Recent (< 4 weeks) intake of proton pump inhibitors, PPI (e.g., omeprazol).
  • Comprehensive tooth-implants or prothesis.
  • Regular intake of anti-inflammatory medication (including NSAIDs).

Más betegség

  • Other confirmed GI diseases (such as inflammatory bowel diseases)
  • Diagnosis of major psychiatric or somatic disease other than PD.
  • Abuse of alcohol or drugs according to Alcohol Use Disorders Identification Test (AUDIT), and/or clinical judgment.
  • Epilepsy.
  • Cerebral bleeding or history of cerebral bleeding.
  • Operated in the heart.
  • Other confirmed GI diseases (such as inflammatory bowel diseases) or PD
  • Diagnosis of major psychiatric or somatic disease. 4) Abuse of alcohol or drugs according to Alcohol Use Disorders Identification Test (AUDIT), and/or clinical judgment.
  • Epilepsy. 6) Cerebral bleeding or history of cerebral bleeding. 7) Pregnancy or breastfeeding (will be asked). 8) Claustrophobia. 9) Smoking or using tobacco including snuff. 10) Dominant left-hand. 13) Inoperated apparatus (e.g., pacemaker). 14) Aneurysm clips in the head. 15) Shunts in the head. 16) Grenade-splinter or metal-splinter in the body (e.g.,eyes). 17) Metal or electrodes in the body (e.g., temp-catheter, aortastent, cochleaimplant).
  • Comprehensive tooth-implants or prothesis. 19) Operated in the head. 20) Operated in the heart. 21) Swallowed a video-capsule. 25) Any other reason the investigator feels the subject is not suitable for participation in the study.
    • Healthy controls:
    • Inclusions criteria:
  • Diagnosis of major psychiatric or somatic disease.
  • Abuse of alcohol or drugs according to Alcohol Use Disorders Identification Test (AUDIT), and/or clinical judgment.
  • Epilepsy.
  • Cerebral bleeding or history of cerebral bleeding.
  • Operated in the heart.

Életkor

  • Males or females aged 18-85

Egyéb

  • Pregnancy or breastfeeding (will be asked).
  • Claustrophobia.
  • Smoking or using tobacco including snuff.
  • Dominant left-hand.
  • Inoperated apparatus (e.g., pacemaker).
  • Aneurysm clips in the head.
  • Shunts in the head.
  • Grenade-splinter or metal-splinter in the body (e.g.,eyes).
  • Metal or electrodes in the body (e.g., temp-catheter, aortastent, cochleaimplant).
  • Operated in the head.
  • Swallowed a video-capsule.
  • Any other reason the investigator feels the subject is not suitable for participation in the study.
    • Patients with IBS
  • Signed informed consent
  • No on going GI symptoms
  • Pregnancy or breastfeeding (will be asked).
  • Claustrophobia.
  • Smoking or using tobacco including snuff.
  • Dominant left-hand.
  • Inoperated apparatus (e.g., pacemaker).
  • Aneurysm clips in the head.
  • Shunts in the head.
  • Grenade-splinter or metal-splinter in the body (e.g., eyes).
  • Metal or electrodes in the body (e.g., temp-catheter, aortastent, cochleaimplant).
  • Operated in the head.
  • Swallowed a video-capsule.
  • Any other reason the investigator feels the subject is not suitable for participation in the study.

Kiket keres a vizsgálat

  • Confirmed diagnosis by neurologist
  • Males or females aged 45-85 years
  • Signed informed consent
  • Fulfilling ROME IV criteria upon recruitment
  • Minimum 5 year of IBS symptoms
  • Males or females aged 18-85 years
  • Signed informed consent

A regiszterben nem jelölt feltételek

  • Patients with Parkinson's disease

Életkor a regiszterben: 18 év – 85 év · Nem: nők és férfiak · Egészséges önkénteseket is fogad

A teljes feltétellista: ClinicalTrials.gov

Helyszínek (1)

Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.

HelyszínVárosOrszágHelyszín állapota
Campus USÖ, Örebro UniversityÖrebroSvédországIsmeretlen állapot

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