NCT07179965

Brief Summary

Aims: This study aimed to assess nutritional status, dietary habits, meal patterns, gastrointestinal symptoms, quality of life, and depression in Inflammatory Bowel Disease (IBD) patients. Methods: Data were collected at a university hospital using the 24-Hour Dietary Recall, IBD Quality of Life Questionnaire, Beck Depression Inventory II, and the Gastrointestinal Symptom Rating Scale.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 5, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 4, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 18, 2025

Completed
Last Updated

September 18, 2025

Status Verified

September 1, 2025

Enrollment Period

2 months

First QC Date

September 4, 2025

Last Update Submit

September 11, 2025

Conditions

Inflammatory Bowel Disease (IBD)InflammationNutritionDiet HabitsGastrointestinal

Keywords

Inflammatory Bowel DiseaseNutritionDietMeal regularity

Outcome Measures

Primary Outcomes (6)

  • Weight

    kg

    Baseline

  • Height

    cm

    Baseline

  • 24-Hour Dietary Recall

    24-Hour Dietary Recall

  • IBD Quality of Life Questionnaire

    To assess quality of life, the "Inflammatory Bowel Disease Quality of Life Questionnaire," consisting of 36 items and evaluating systemic symptoms, bowel symptoms, functional impairment, social impairment, and emotional functioning, was used. A higher score is associated with better quality of life.

    Baseline

  • Beck Depression Inventory II

    The Beck Depression Inventory-II (BDI-II), a 21-item self-report questionnaire assessing characteristic attitudes and symptoms of depression, was administered at baseline (single time point, at questionnaire administration). Each item is scored on a 4-point scale (0-3), with a total score range of 0-63. Higher scores indicate greater severity of depression, classified as minimal (0-13), mild (14-19), moderate (20-28), and severe (29-63).

    Baseline

  • Gastrointestinal Symptom Rating Scale

    The Gastrointestinal Symptom Rating Scale (GSRS), a 15-item questionnaire comprising five subcategories (abdominal pain, indigestion, diarrhea, constipation, and reflux), was administered at baseline (single time point, at questionnaire administration). Each item is scored on a 7-point Likert scale (1-7), yielding a total score range of 15-105, with higher scores indicating more severe gastrointestinal symptoms.

    Baseline

Study Arms (1)

Inflammatory Bowel Disease patients

OTHER
Other: Observation

Interventions

ObservationOTHER

IBD patients

Inflammatory Bowel Disease patients

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Individuals with psychiatric disorders, or those who were pregnant or breastfeeding, were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University Cerrahpaşa

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

  • Alavinejad P, Hashemi SJ, Behl N, Hormati A, Elbasuny A, Daryani NE, Modarres MP, Arshadzadeh M, Panahande S, Hang DV, Mahros AM, Parsi A, Javaherizadeh H, Rehman A, Pawlak KM, Ahmadi M, Ahmed MH, Farsi F, Arefi M, Quadri A, Tran QT, Alborzi F, Amin Alavi SM, Cheraghian B, Ramezani E, Gouda MF, Saadati B, Quadri AA, Hirani R, Maher M, Ghoneem E. Inflammatory bowel disease evolution in the past two decades: a chronological multinational study. EClinicalMedicine. 2024 Mar 15;70:102542. doi: 10.1016/j.eclinm.2024.102542. eCollection 2024 Apr.

    PMID: 38525407BACKGROUND

MeSH Terms

Conditions

Inflammatory Bowel DiseasesInflammationFeeding Behavior

Interventions

Observation

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsBehavior, AnimalBehavior

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: Cross sectional
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

September 4, 2025

First Posted

September 18, 2025

Study Start

August 1, 2023

Primary Completion

September 30, 2023

Study Completion

August 5, 2025

Last Updated

September 18, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)