The study tests whether BugSpeaks , a personalized diet based on gut bacteria, can improve the quality of life of cervical cancer patients undergoing chemo-radiotherapy.

A prospective, randomized, open label study to evaluate safety and efficacy of BugSpeaks , a microbiota based personalised diet on the quality of life of patients undergoing concurrent chemo-radiotherapy for Carcinoma Cervix of squamous histology. - NA

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/04/086081

Enrollment

Registered

2025-04-30

Start date

Unknown

Completion date

Unknown

Last updated

2025-05-26

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

Conditions

Health Condition 1: C539- Malignant neoplasm of cervix uteri, unspecified

Interventions

Intervention1: BugSpeaks based personalized nutrition: BugSpeaks , is a non-invasive gut microbiota profiling test which profiles the gut microbiota and provides personalised nutritional recommendati

Eligibility

Inclusion criteria

Inclusion criteria: 1)Cervical Cancer(Of Squamous Histology) Stage III and IV, Undergoing chemoradiotherapy. 2) Signed Informed Consent Form. 3)Patients who agrees to follow personalised diet for 3 months. 4) Karnofsky Performance Score Greater than 70.

Exclusion criteria

Exclusion criteria: 1) Individuals with Gastritis, Colitis, Irritable Bowel Syndrome, Pseudomembranous Colitis and Crohns disease. 2) Individuals with autoimmune diseases and or under treatment with corticosteroids and or immunosuppressants. 3)Individuals with major surgeries within the last 1 month or gastrointestinal surgery in the last 3month. 4)Operated patients for carcinoma cervix. 5) Individuals undergoing dietary restriction and or pharmacological treatment for the decrease of body weight 2 months prior to the beginning of the study. 6) Women on Oral contraceptive Pills. 7) Individuals with Intensive Physical Activity (More than 2 hours,3 times per week). 8) Individual taking prebiotics or probiotics during the 4 weeks prior to the beginning of the study. 9) Alcoholic or Drug addicted Individuals. 10) Individuals with regular use of Laxatives ( More than 2 times per week)

Design outcomes

Primary

Measure	Time frame
To study the effects of microbiota based personalised diet on quality-of-life parameters of cervical cancer patients undergoing chemo and radiotherapy.Timepoint: Day 1 to day 90	—

Secondary

Measure	Time frame
To evaluate any Adverse Event or Discomfort occurring due to BugSpeaks based personalised nutrition.Timepoint: Day 1 to day 90	—

Countries

India

Contacts

Public ContactDr Mukul Maurya

Leucine Rich Bio Pvt Ltd

ddhar@leucinerichbio.com981839509

Outcome results

None listed

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