Table 7.
Tolerance parameters of infants in the synbiotic and control groups in the intention-to-treat population
(Mean values and standard deviations, and number of infants)
| Synbiotic | Control | ||||||
|---|---|---|---|---|---|---|---|
| Parameter | Time (weeks) | Mean | sd | n | Mean | sd | n |
| Stool frequency (n/d) | 0–4 | 1·4 | 0·97 | 95 | 1·5 | 0·93 | 105 |
| 4–8 | 1·2 | 0·72 | 77 | 1·2 | 0·65 | 79 | |
| 8–13 | 1·1† | 0·59 | 74 | 1·2 | 0·56 | 74 | |
| Stool consistency score‡ | 0–4 | 2·2* | 0·8 | 95 | 2·3 | 0·7 | 105 |
| 4–8 | 2·1 | 0·5 | 77 | 2·2 | 0·6 | 79 | |
| 8–13 | 2·1 | 0·5 | 74 | 2·2 | 0·6 | 74 | |
| Constipation severity§ | 0–4 | 0·1 | 0·5 | 89 | 0·2 | 0·6 | 103 |
| 4–8 | 0·0 | 0·2 | 71 | 0·0 | 0·1 | 76 | |
| 8–13 | 0·0 | 0·0 | 68 | 0·0 | 0·1 | 71 | |
| Diarrhoea severity | 0–4 | 0·1 | 0·3 | 89 | 0·1 | 0·3 | 101 |
| 4–8 | 0·0 | 0·2 | 71 | 0·0 | 0·1 | 76 | |
| 8–13 | 0·0 | 0·1 | 68 | 0·0 | 0·1 | 71 | |
| Colic severity | 0–4 | 0·2 | 0·6 | 89 | 0·2 | 0·6 | 103 |
| 4–8 | 0·1 | 0·4 | 72 | 0·2 | 0·6 | 79 | |
| 8–13 | 0·0 | 0·2 | 68 | 0·0 | 0·2 | 72 | |
| Vomiting severity | 0–4 | 0·1 | 0·3 | 90 | 0·2 | 0·6 | 103 |
| 4–8 | 0·1 | 0·3 | 72 | 0·1 | 0·3 | 77 | |
| 8–13 | 0·1 | 0·2 | 68 | 0·0 | 0·2 | 71 | |
| Regurgitation severity | 0–4 | 0·8 | 0·8 | 91 | 0·8 | 0·7 | 106 |
| 4–8 | 0·7 | 0·7 | 74 | 0·7 | 0·7 | 79 | |
| 8–13 | 0·7 | 0·7 | 71 | 0·7 | 0·8 | 74 | |
| Flatulence severity | 0–4 | 0·9 | 0·9 | 91 | 0·8 | 0·8 | 105 |
| 4–8 | 0·8 | 0·8 | 75 | 0·7 | 0·8 | 79 | |
| 8–13 | 0·6 | 0·8 | 71 | 0·5 | 0·6 | 74 | |
| Nappy rash severity | 0–4 | 0·0 | 0·3 | 88 | 0·1 | 0·3 | 103 |
| 4–8 | 0·1 | 0·3 | 71 | 0·1 | 0·2 | 77 | |
| 8–13 | 0·1 | 0·3 | 68 | 0·1 | 0·3 | 73 | |
| Crying severity‖ | 0–13 | 4·1 | 1·9 | 93 | 4·1 | 2·1 | 101 |
| Sleeping score‖ | 0–13 | 7·2 | 1·9 | 94 | 7·1 | 2·0 | 101 |
Mean value was significantly different from that for the control group (P < 0·05).
Mean value tended to be significantly different from that for the control group (0·10 > P > 0·05).
Consistency scores: 1 = watery; 2 = soft/pudding like; 3 = soft formed; 4 = dry formed; 5 = dry/hard pellets.
Severity scores: 0 = absent; 1 = mild; 2 = moderate; 3 = severe.
Crying frequency and sleeping scores were measured on a ten-point scale: a rating of 10 for sleeping is very good; a rating of 10 for crying is very often. Stool consistency and gastrointestinal symptoms comparisons were tested using the Jonckheere–Terpstra test, stool frequency comparisons were tested using the Mann–Whitney test.