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To evaluate Gut Brain Axis on cerebral Palsy children

Correlation of neurocognitive and motor function deficit severity with gut physiology in Cerebral palsy children - CP-GUT0001

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/10/046338
Enrollment
82
Registered
2022-10-11
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: Q663- Other congenital varus deformitiesof feet

Interventions

Intervention1: already taking Intervention: patients already on Intervention Group I: a) CP+ without Gut Disturbances (Control) Group II: b) CP + Gut Disturbances Group III:

Sponsors

DrSuman Jain
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Age 5-15 years. 2.All type of cerebral palsy Spastic CP or 3.Dyskinetic CP or Ataxic CP or Mixed CP with 4.Hemiplegia and Diplegia. 5.Intelligence quotient >50 (Binet Kamat test/ Malinââ?¬•s Intelligence scale for children). 6.Modified Ashworth scoring 1-3 for affected limb . 7.Can sit independently or with support (GMFCS stage: 1-4 and Manual ability classification system stage:1-3) . 7.Preserved vision and hearing (with or without correction). 8.Ability to follow instructions and complete testing or Task. 9.No formal cognitive assessment was performed in past 6 months.

Exclusion criteria

Exclusion criteria: 1.Uncontrolled epilepsy as defined by seizure 2.frequency > 1/month for preceding 3 months. 3.� Severe concurrent illness of disease not 4.associated with CP or unstable medical conditions like pneumonia 5.Genetic or syndromic associations. 6.Children diagnosed with autistic spectrum disorders. 7.Modified Ashworth scale score >3 at shoulder/elbow/wrist. 8.Contractures of affected limb. 9.Severe movement disorder like dystonia, choreo-athetosis or ballismus interfering with purposeful limb movement. 10.Any congenital brain malformation detected on conventional MRI brain. 11.Any Malignancy/Cyst formation in the brain CT Scan or MRI Scan. 12.Recent orthopaedic surgery/ cast/splint in affected limb or any metallic implant. 13.Those receiving tone modifying agents. On proton pump inhibitors 2 weeks before sample collection.

Design outcomes

Primary

MeasureTime frame
1.To investigate the alterations in gut motility, cognitive functions and cortical excitability in Cerebral Palsy Children. 2.To correlate the impairment in gut motility, Autonomic Functions with severity of motor and cognitive deficits in CP. 3.To compare the impairment of gut ââ?¬â??brain axis among All CP Patients. Timepoint: just before the intervention and after the intervention

Secondary

MeasureTime frame
1.To investigate the effect of probiotic on Gut motility ,motor ,cognitive deficits and cortical excitability in CP children. 2.To assess metabolomic profiling of CP children by using LC MSMS. Timepoint: 1.To investigate the effect of probiotic on Gut motility ,motor ,cognitive deficits and cortical excitability in CP children. 2.To assess metabolomic profiling of CP children by using LC MSMS. ;1.To investigate the effect of probiotic on Gut motility ,motor ,cognitive deficits and cortical excitability in CP children. 2.To assess metabolomic profiling of CP children by using LC MSMS. Timepoint: 1.To investigate the effect of probiotic on Gut motility ,motor ,cognitive deficits and cortical excitability in CP children. 2.To assess metabolomic profiling of CP children by using LC MSMS.

Countries

India

Contacts

Public ContactAliya Mufti

All India Institute of Medical sciences, New Delhi

aliyamuftiaiims@gmail.com07838072483

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026