Effect of Low Fermentable, Oligo-, di-, Monosaccharides and Polyols (FODMAP) Diet on Improving Symptoms of Patients With Irritable Bowel Syndrome (Randomized Control Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 183
- 试验地点
- 2
- 主要终点
- Irritable Bowel Syndrome-Quality of Life Measure (IBS-QOL)
研究概览
简要总结
Irritable bowel syndrome (IBS) is a common disorder of gut-brain interaction, characterized by chronic abdominal pain and altered bowel habits. A low-FODMAP diet (LFD), which restricts specific types of fermentable carbohydrates, significantly reduces IBS symptoms and improves quality of life (QoL). Objectives: To evaluate the short- and long-term effects of LFD on improving symptom severity and the quality of life of IBS patients attending the family medicine outpatient clinic, and to assess LFD acceptability and adherence of IBS patients. Methods: Randomized control trial conducted on (123 patients) with IBS attending outpatient clinic of family medicine at Tenth of Ramadan University Hospital from 1st of June 2024 to the end of June 2025. An intervention group (No=93) received patient-centered education about LFD, and a control group (No.=90). Participants in both groups underwent an assessment of their BMI, Irritable Bowel Syndrome- Severity Scoring System (IBS-SSS), and irritable bowel syndrome-Quality of Life Measure (IBS-QOL) preintervention during the first visit and reassessed post-intervention after one, three, and six months. Additionally, Patients in the intervention group were assessed for the FODMAP Adherence Report Scale (FARS), LFD acceptability questionnaire, and Food-related QOL questionnaire at one, three-, and six-month post-intervention phases.
详细描述
A randomized control trial open-label trial was conducted from 1st June 2024 to the end of June 2025 at the family medicine clinic, Tenth of Ramadan University Hospital- Sharkia governorate. It was selected due to the high rate of attendance and the availability of repeated follow-up visits. The study was conducted in accordance with CONSORT guidelines, and a flowchart was used to illustrate the participant selection and allocation process.
The study included 93patients in intervention group and 90 patients in control group who newly diagnosed with IBS based on Rome IV criteria and subtypes of IBS included constipation-predominant, diarrhea predominant, mixed, and unspecified, according to Bertin et al., (2024), aged 18 to 60 years old of both genders, after taking their consent to participate. Exclude Patients who previously diagnosed with GI comorbidities, such as inflammatory bowel disease, celiac disease, lactose malabsorption, significant diverticular disease, or a history of bowel resection, Clinically significant systemic disease, pregnant or lactating, drug abuse, serious psychiatric diseases, or eating disorders, Presence of blood or pus in stool analysis, Individuals with IBS-alarming symptoms as (did not have a normal colonoscopy).
- Sample size: Assuming IBS severity score after 6 weeks was 153+136 vs. 199+102 in LFD VS LGG diet according to (Pedersen et al., 2014), at 80% power and 95 % CI, the estimated sample was 216 cases, 108 cases in each group using the open epi program version 6 at C.I 95%.
- Sampling technique: The sample was collected by a systematic random sample technique. The sample was classified randomly according to intervention type into two groups (108 each group) by block randomaization using sealed Envelope website. The participants were classified into 12 blocks (6 block in each group) each block size 18 list length with allocation ratio 1:1, Study was open-label. There was drop out in both intervention and control group, 15 patients were dropped out from intervention group and 21 from control group so the number of participants which completed the study were 93 in intervention group and 90 in control group.
Study methods:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •newly diagnosed with IBS based on Rome IV criteria and subtypes of IBS included constipation-predominant, diarrhea predominant, mixed, and unspecified,
- •aged 18 to 60 years old of both genders,
- •after taking their consent to participate
排除标准
- •Patients who previously diagnosed with GI comorbidities (such as inflammatory bowel disease, celiac disease, lactose malabsorption, significant diverticular disease, or a history of bowel resection)
- •Clinically significant systemic disease
- •pregnant or lactating
- •drug abuse
- •serious psychiatric diseases
- •eating disorders
- •Presence of blood or pus in stool analysis
- •Individuals with IBS-alarming symptoms as (did not have a normal colonoscopy)
结局指标
主要结局
Irritable Bowel Syndrome-Quality of Life Measure (IBS-QOL)
时间窗: 6 months
The IBS-QOL is a self-report quality-of-life measure specific to IBS that can be used to assess the impact of IBS and its treatment. It consists of 34 items, each with a five-point response scale ( preintervention, postintervention at 1st, 3rd and 6th month)
IBS severity symptoms score (IBS-SSS)
时间窗: 6 months
The IBS-SSS is a 5-question assessment to appraise the severity, frequency of abdominal pain, intensity of abdominal distention, frustration with bowel habits, and intrusion in quality of life 10 days ago ( preintervention and postintervention at 1st month, 3rd month, 6th month
次要结局
- Body Mass Index(6 months)