Effect of a high-fibre diet on disease remission in newly diagnosed multiple myeloma patients

Feasibility of high fibre dietary intervention in newly diagnosed Multiple Myeloma patients and its effect on gut microbiome and disease remission. - Nil

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/02/103522

Enrollment

Registered

2026-02-10

Start date

Unknown

Completion date

Unknown

Last updated

2026-03-02

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

Conditions

Health Condition 1: C900- Multiple myeloma

Interventions

Intervention1: high fibre dietary intervention in newly diagnosed Multiple Myeloma patients: Stool samples collected at baseline and 4 months post chemotherapy Control Intervention1: Nil: Nil

Eligibility

Inclusion criteria

Inclusion criteria: Newly diagnosed Multiple Myeloma patients Aged 18 to 60 years Who will be treated with Lenalidomide/Bortezomib/Dexamethasone induction [VLD] chemotherapy.

Exclusion criteria

Exclusion criteria: Relapsed Multiple Myeloma Patient with inflammatory bowel disease or other contraindications for a high-fibre diet Multiple Myeloma with renal failure at diagnosis

Design outcomes

Primary

Measure	Time frame
Analysis of the change in gut microbiota composition from baseline after the introduction of a high fibre diet in patients with multiple myeloma receiving induction chemotherapy. Taxonomic classification and relative abundance of the butyrate-producing gut microbiota from baseline to myeloma patients with post high fibre-rich diet undergoing chemotherapy Mean change in stool microbiome alpha diversity from baseline after 4 months of high fibre diet Mean change in butrate producers individually and in total-Firmicutes, Actinobacteria, Bacteroidetes, Fusobacteria(4) after 4 months of high fibre diet from the baseline. Percentage of people with relative abundance of firmicutes, actinobacteria, bacteroidetes, and fusobacteria at the end of 4 months of high fibre diet from the baseline. Timepoint: 1 year 6 months	—

Measure

Time frame

Analysis of the change in gut microbiota composition from baseline after the introduction of a high fibre diet in patients with multiple myeloma receiving induction chemotherapy. Taxonomic classification and relative abundance of the butyrate-producing gut microbiota from baseline to myeloma patients with post high fibre-rich diet undergoing chemotherapy Mean change in stool microbiome alpha diversity from baseline after 4 months of high fibre diet Mean change in butrate producers individually and in total-Firmicutes, Actinobacteria, Bacteroidetes, Fusobacteria(4) after 4 months of high fibre diet from the baseline. Percentage of people with relative abundance of firmicutes, actinobacteria, bacteroidetes, and fusobacteria at the end of 4 months of high fibre diet from the baseline. Timepoint: 1 year 6 months

—

Secondary

Measure	Time frame
Tolerability and acceptability to the high fibre diet measured by Percentage of days where diet recommendations were followed Percentage of patients with high GI symptoms score with respect to patient reported GI symptoms scoring based on the GSRS questionnaire done weekly Percentage of patients with good satisfaction and acceptance based on patient reported diet tolerability and acceptance based on the 45 item Diet Satisfaction Questionnaire done monthly Average daily fibre intake as assessed by a dietician based on diet diary Percentage of emergency visits with GI symptoms and frequency of emergency visits. Percentage of grade 3 or grade 4 adverse events as measured weekly. Timepoint: 1 year 6 months	—

Measure

Time frame

Tolerability and acceptability to the high fibre diet measured by Percentage of days where diet recommendations were followed Percentage of patients with high GI symptoms score with respect to patient reported GI symptoms scoring based on the GSRS questionnaire done weekly Percentage of patients with good satisfaction and acceptance based on patient reported diet tolerability and acceptance based on the 45 item Diet Satisfaction Questionnaire done monthly Average daily fibre intake as assessed by a dietician based on diet diary Percentage of emergency visits with GI symptoms and frequency of emergency visits. Percentage of grade 3 or grade 4 adverse events as measured weekly. Timepoint: 1 year 6 months

—

Countries

India

Contacts

Public ContactDr Sreeraj V

Amala Institute of Medical sciences

sreerajfleming@gmail.com8826752985

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 14, 2026