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Table 5 Between and within group comparisons at weeks 8 and 12

From: A randomised controlled trial of a probiotic ‘functional food’ in the management of irritable bowel syndrome

WEEK 8

Study parameter

A = Active product

C = Control product

A vs C

 

n

Mean (week 12–baseline) (SD)

p value* (change from baseline)

n

Mean (week 12–baseline) (SD)

p value* (change from baseline)

p value**

IBS-SSS

50

−58.30 (84.96)

<0.001

40

−58.33 (73.37)

<0.001

0.589

Birmingham IBS symptom scale

Constipation

52

13.78 (24.47)

<0.001

41

17.24 (22.61)

<0.001

0.302

Diarrhoea

4.25 (13.78)

0.210

2.15 (7.71)

0.064

0.907

Pain

11.28 (18.88)

<0.001

13.66 (16.80)

<0.001

0.257

Total score

8.71 (13.09)

<0.001

9.44 (9.75)

<0.001

0.265

IBS specific symptoms

Pain

53

−0.58 (1.24)

0.012

41

−0.66 (1.43)

0.002

0.292

Bloating

52

−0.80 (1.44)

0.005

−0.85 (1.26)

<0.001

0.408

Flatulence

53

−0.54 (1.28)

0.002

40

−0.50 (1.08)

0.004

0.864

Composite score

52

−1.95 (3.43)

0.003

−1.96 (3.17)

<0.001

0.374

Stool frequency

346

0.07 (0.95)

0.303

276

0.10 (0.05)

0.141

0.828

Stool consistency

290

0.18 (1.17)

0.042

218

0.50 (1.23)

0.001

0.098

Bowel movement difficulty

291

−0.43 (1.01)

<0.001

224

−0.40 (0.78)

<0.001

0.623

IBS Quality of life

Dysphoria

53

14.66 (19.87)

<0.001

41

9.29 (13.95)

<0.001

0.508

Activity interference

8.20 (14.74)

0.001

6.05 (12.99)

0.001

0.924

Body image

11.95 (15.98)

<0.001

8.54 (13.46)

<0.001

0.735

Health worry

13.29 (17.81)

<0.001

7.62 (15.19)

0.002

0.428

Food avoidance

10.06 (17.63)

<0.001

5.49 (17.84)

0.039

0.372

Social reaction

10.85 (16.18)

<0.001

6.71 (12.21)

<0.001

0.462

Sexual

8.41 (18.31)

0.006

7.05 (16.92)

0.005

0.554

Relationship

7.23 (18.64)

0.015

7.01 (9.88)

<0.001

0.635

Total score

10.95 (13.14)

<0.001

7.52 (10.22)

<0.001

0.483

WEEK 12

IBS-SSS

43

−61.02 (75.78)

<0.001

33

−97.24 (90.17)

<0.001

0.028

Birmingham IBS symptom scale

Constipation

48

6.65 (22.56)

0.039

35

17.52 (23.60)

<0.001

0.011

Diarrhoea

 

3.27 (11.17)

0.048

 

2.43 (10.60)

0.133

0.889

Pain

 

10.28 (14.09)

<0.001

 

15.24 (17.38)

<0.001

<0.107

Total score

 

6.07 (9.62)

<0.001

 

10.10 (10.78)

<0.001

<0.022

IBS specific symptoms

Pain

48

−0.59 (1.24)

0.002

34

−1.04 (1.33)

<0.001

0.016

Bloating

48

−0.58 (1.39)

0.005

−1.35 (1.21)

<0.001

0.006

Flatulence

48

−0.64 (1.04)

0.001

−0.76 (1.23)

<0.001

0.383

Composite score

48

−1.81 (3.03)

<0.001

−3.16 (3.05)

<0.001

0.011

Stool frequency

311

−0.07 (0.75)

0.186

224

0.07 (0.82)

0.464

0.211

Stool consistency

247

0.26 (1.22)

0.045

181

0.31 (0.99)

0.012

0.784

Bowel movement difficulty

246

−0.35 (0.99)

<0.001

180

−0.36 (0.86)

<0.001

0.329

IBS Quality of life

Dysphoria

48

13.61 (20.12)

<0.001

34

10.83 (10.68)

<0.001

0.933

Activity interference

8.47 (12.31)

<0.001

34

7.09 (8.73)

<0.001

0.806

Body image

11.33 (14.16)

<0.001

34

8.27 (14.08)

0.005

0.857

Health worry

14.15 (21.01)

<0.001

34

9.07 (13.19)

<0.001

0.634

Food avoidance

8.16 (20.45)

0.008

34

8.58 (13.37)

<0.001

0.687

Social reaction

9.64 (17.15)

<0.001

34

9.38 (8.74)

<0.001

0.660

Sexual

8.07 (21.34)

0.031

32

10.55 (16.53)

<0.001

0.382

Relationship

7.03 (15.81)

0.002

34

5.51 (9.22)

<0.001

0.751

Total score

 

10.43 (12.92)

<0.001

34

8.83 (6.12)

<0.001

0.810

  1. *ANCOVA with centre as a random effect, baseline as a covariate and product as a fixed effect.
  2. **Ordinal logistic regression with centre and product fixed effects.
  3. Stool frequency, consistency and bowel movement difficulty were recorded daily and therefore n represents the number of data items (days) included in analysis for these items.